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Job Description
**PXL FSP is seeking LSADs in Canada! This is a remote role. Oncology experience is required for this role and cell therapy is strongly preferred!**
The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The LSAD may perform site monitoring as needed to support the flexible capacity model.
The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
**Trial and Site Administration**
+ Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
+ Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
+ Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
+ Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
+ Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
+ Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
+ Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
+ Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
+ Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.
+ Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
+ Proactively identifies risks and facilitates resolution of complex study problems and issues.
+ Organizes regular Local Study Team meetings on an agenda driven basis.
+ Actively works towards achieving good personal relationships with all Local Study Team members, sites' staff and global stakeholders.
+ Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.
+ Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
+ Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
+ Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
+ Plans and leads National Investigator meetings, in line with local codes, as required.
+ Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
+ Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
+ Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
+ Provides input to process development and improvement.
+ Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
+ Updates Line Managers about the performance of the CRAs/CSAs.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Affairs team.
+ Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management
**Document Management**
+ Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
+ Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
+ Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready".
+ Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
**Regulatory and Site Start Up Responsibilities**
+ Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
+ Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.
**Budgeting, Agreements and Payments**
+ Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
+ Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.
+ Ensures accurate payments related to the study are performed according to local regulations and agreements.
**Compliance with Sponsor Standards**
+ Ensures compliance with Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
+ Ensures that study activities at country level comply with local policies and code of ethics.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
+ Excellent project management skills.
+ Excellent team building and interpersonal skills.
+ Excellent organizational skills.
+ Excellent verbal and written communication skills.
+ Excellent ability to prioritize and handle multiple tasks.
+ Excellent attention to detail.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
+ Good negotiation skills.
+ Good ability to learn and to adapt to work with IT systems.
**Skills (Desirable):**
+ Good analytical skills.
+ Good resource management skills.
+ Good decision making and delegation skills.
+ Good financial management skills.
+ Basic change management skills.
+ Basic coaching skills.
+ Basic ability in handling crisis situations.
**Knowledge and Experience (Essential)** :
+ Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
+ Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
**Knowledge and Experience (Desirable):**
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Good knowledge of the Drug Development Process.
+ Excellent understanding of the Clinical Study Process including monitoring.
+ Very good understanding of the Study Drug Handling Process and the Data Management Process.
+ Good intercultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other** **:**
+ Ability to travel nationally and internationally as required.
+ Integrity and high ethical standards.
**EEO Disclaimer**
**Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**
\#LI-KW1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The LSAD may perform site monitoring as needed to support the flexible capacity model.
The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
**Trial and Site Administration**
+ Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
+ Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
+ Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
+ Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
+ Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
+ Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
+ Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
+ Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
+ Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.
+ Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
+ Proactively identifies risks and facilitates resolution of complex study problems and issues.
+ Organizes regular Local Study Team meetings on an agenda driven basis.
+ Actively works towards achieving good personal relationships with all Local Study Team members, sites' staff and global stakeholders.
+ Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.
+ Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
+ Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
+ Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
+ Plans and leads National Investigator meetings, in line with local codes, as required.
+ Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
+ Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
+ Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
+ Provides input to process development and improvement.
+ Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
+ Updates Line Managers about the performance of the CRAs/CSAs.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Affairs team.
+ Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management
**Document Management**
+ Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
+ Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
+ Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF "Inspection Ready".
+ Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
**Regulatory and Site Start Up Responsibilities**
+ Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
+ Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.
**Budgeting, Agreements and Payments**
+ Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
+ Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.
+ Ensures accurate payments related to the study are performed according to local regulations and agreements.
**Compliance with Sponsor Standards**
+ Ensures compliance with Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
+ Ensures that study activities at country level comply with local policies and code of ethics.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
+ Excellent project management skills.
+ Excellent team building and interpersonal skills.
+ Excellent organizational skills.
+ Excellent verbal and written communication skills.
+ Excellent ability to prioritize and handle multiple tasks.
+ Excellent attention to detail.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
+ Good negotiation skills.
+ Good ability to learn and to adapt to work with IT systems.
**Skills (Desirable):**
+ Good analytical skills.
+ Good resource management skills.
+ Good decision making and delegation skills.
+ Good financial management skills.
+ Basic change management skills.
+ Basic coaching skills.
+ Basic ability in handling crisis situations.
**Knowledge and Experience (Essential)** :
+ Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
+ Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
**Knowledge and Experience (Desirable):**
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Good knowledge of the Drug Development Process.
+ Excellent understanding of the Clinical Study Process including monitoring.
+ Very good understanding of the Study Drug Handling Process and the Data Management Process.
+ Good intercultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other** **:**
+ Ability to travel nationally and internationally as required.
+ Integrity and high ethical standards.
**EEO Disclaimer**
**Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**
\#LI-KW1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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0
Job Description
$41.38-$48.28 per hour
Mississauga, ON
Contract
**Duration: 12 months (possible extension)**
**Description:**
**Purpose, Objectives and Scope of Position**
+ The Country Study Manager (CSM) provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Client quality standards, all applicable regulations, timelines and budget commitments.
+ For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT) For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.
**Key Responsibilities**
+ Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Client planning system.
+ Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required. Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
+ Plans and executes country study goals and commitments and ensures compliance to relevant processes.
+ May serve as global Country Study Representative (CSR), as part of global study team. Coaches and provides support to responsible study team members.
+ Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
+ Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
+ Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
+ Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Client studies.
+ Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required
**Qualifications**
**Education**
+ Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master's degree will be valued but not required (depending on each country's requirements).
**Experience**
+ Experience in the pharmaceutical or related industry.
+ Experience in end-to-end product development.
+ Understanding of end-to-end clinical trial processes, and strong knowledge of clinical trial regulations and guidelines.
+ Proven track record in managing site relationships and overseeing complex clinical trials.
+ Fluency in written and spoken English is mandatory.
+ Fluency in written and spoken language(s) of the host country is mandatory.
+ Ability to travel to meet the demands of the job: travel to sites on an on-going basis to establish and maintain strong working relationships. Frequent International and/or domestic travel may be required.
**Skills**
+ Demonstrated customer centric mindset and behaviors, building trust and positive and strong sustainable relationships with external and internal stakeholders and CROs.
+ Exceptional communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders.
+ Proven influencing and negotiation skills.
+ Problem-solving: Proactively identify challenges and develop effective solutions by using analytical thinking, tools, and judgement.
+ Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
+ Team Collaboration: Ability to work within cross-functional teams and foster collaborative relationships.
+ Strategic Leadership with the ability to demonstrate flexibility and agility working cross-functionally and leading through ambiguity.
+ Critical thinking and growth mindset.
+ High ethical standards and professionalism.
+ Proactive, results-driven attitude
**Impact Levels**
+ Solid clinical research knowledge and expertise in clinical trial operations, DA portfolio knowledge, cultural awareness and local language(s) management to deliver a site-facing customer experience focused on efficiency and speed. Good understanding of end-to-end clinical trial process.
+ Good communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders. Demonstrate good influencing and negotiation skills.
+ Demonstrated solid customer centric mindset and behaviors, building trust, positive and strong sustainable relationships with external stakeholders to ensure high levels of site satisfaction. Experience in managing and maintaining solid site relationships.
+ Proactively identifies challenges and develops effective solutions by using analytical thinking, tools, and judgement.
+ Demonstrated ability to work within cross-functional teams and foster collaborative relationships. At sites participating in clinical trials, builds strong relationships to engage on study level topics.
**Qualification Levels**
+ Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master's degree will be valued but not required (depending on each country's requirements)
+ Experience in the pharmaceutical or related industry.
+ Experience in product development.
+ Good understanding of end-to-end clinical trial processes, and solid knowledge of clinical trial regulations and guidelines.
+ Experience in managing site relationships and overseeing clinical trials.
**Note:**
+ Work Location: This is a remote role. Candidate is not mandated to work from the office but must reside in Canada
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
**AI Statement:** By applying, you acknowledge that AI-assisted tools may be used during hiring.
Mississauga, ON
Contract
**Duration: 12 months (possible extension)**
**Description:**
**Purpose, Objectives and Scope of Position**
+ The Country Study Manager (CSM) provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Client quality standards, all applicable regulations, timelines and budget commitments.
+ For Global/Regional Studies (referred as Global), the CSM leads and has full accountability (time, quality, cost) in alignment with the Study Management Team (SMT) For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for the local study team.
**Key Responsibilities**
+ Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Client planning system.
+ Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required. Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
+ Plans and executes country study goals and commitments and ensures compliance to relevant processes.
+ May serve as global Country Study Representative (CSR), as part of global study team. Coaches and provides support to responsible study team members.
+ Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
+ Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
+ Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
+ Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Client studies.
+ Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required
**Qualifications**
**Education**
+ Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master's degree will be valued but not required (depending on each country's requirements).
**Experience**
+ Experience in the pharmaceutical or related industry.
+ Experience in end-to-end product development.
+ Understanding of end-to-end clinical trial processes, and strong knowledge of clinical trial regulations and guidelines.
+ Proven track record in managing site relationships and overseeing complex clinical trials.
+ Fluency in written and spoken English is mandatory.
+ Fluency in written and spoken language(s) of the host country is mandatory.
+ Ability to travel to meet the demands of the job: travel to sites on an on-going basis to establish and maintain strong working relationships. Frequent International and/or domestic travel may be required.
**Skills**
+ Demonstrated customer centric mindset and behaviors, building trust and positive and strong sustainable relationships with external and internal stakeholders and CROs.
+ Exceptional communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders.
+ Proven influencing and negotiation skills.
+ Problem-solving: Proactively identify challenges and develop effective solutions by using analytical thinking, tools, and judgement.
+ Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
+ Team Collaboration: Ability to work within cross-functional teams and foster collaborative relationships.
+ Strategic Leadership with the ability to demonstrate flexibility and agility working cross-functionally and leading through ambiguity.
+ Critical thinking and growth mindset.
+ High ethical standards and professionalism.
+ Proactive, results-driven attitude
**Impact Levels**
+ Solid clinical research knowledge and expertise in clinical trial operations, DA portfolio knowledge, cultural awareness and local language(s) management to deliver a site-facing customer experience focused on efficiency and speed. Good understanding of end-to-end clinical trial process.
+ Good communication and interpersonal skills, with the ability to build and maintain positive relationships with site personnel, and other external and internal stakeholders. Demonstrate good influencing and negotiation skills.
+ Demonstrated solid customer centric mindset and behaviors, building trust, positive and strong sustainable relationships with external stakeholders to ensure high levels of site satisfaction. Experience in managing and maintaining solid site relationships.
+ Proactively identifies challenges and develops effective solutions by using analytical thinking, tools, and judgement.
+ Demonstrated ability to work within cross-functional teams and foster collaborative relationships. At sites participating in clinical trials, builds strong relationships to engage on study level topics.
**Qualification Levels**
+ Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Postgraduate degree or master's degree will be valued but not required (depending on each country's requirements)
+ Experience in the pharmaceutical or related industry.
+ Experience in product development.
+ Good understanding of end-to-end clinical trial processes, and solid knowledge of clinical trial regulations and guidelines.
+ Experience in managing site relationships and overseeing clinical trials.
**Note:**
+ Work Location: This is a remote role. Candidate is not mandated to work from the office but must reside in Canada
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
**AI Statement:** By applying, you acknowledge that AI-assisted tools may be used during hiring.
Is this job a match or a miss?
Apply Now
1
Job Description
Country Study Operations Manager
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.
**What You Will Be Doing:**
+ Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
+ May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
+ Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
+ Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
+ Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
+ Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
+ Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
+ Ensures compliance to relevant Global and Local, internal and external requirements and regulations
+ Ensures timely communication bidirectionally between the global and local study team.
+ Provides protocol level guidance and support to responsible Local Study Team members as applicable.
+ Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
+ Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
+ Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
+ Follows up on region/country level issue status to ensure resolution.
+ Identifies country level trends to improve deliverables processes as needed
+ Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
+ Ensures audit/Inspection readiness during start-up and conduct
+ Manages applicable Quality Events with pCRO and local team as applicable and required
+ Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
+ Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
+ Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
+ May act as a Subject Matter Expert
+ May lead operational effectiveness initiatives at country or regional level
+ Responsible for PTA and SIV report review for reports completed by the Site Care Partner
+ Supports implementation of client's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
+ Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
+ Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
+ Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
+ Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
+ Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
+ Support Identification, contract development and management of local vendors or facilities as per protocol
+ Investigator Meeting support and management including doing presentations as appropriate
+ Management of local Investigator Meetings including doing presentations as appropriate
**What you need to have:**
+ A scientific or technical degree is preferred along with knowledge of clinical trial methodology
+ BS/BSc/MS/MSc degree required
+ BA/BS 5+ years of relevant experience operational clinical trial experience
+ MBA/MS/ 3+ years of relevant experience operational clinical trial experience
+ Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
+ Demonstrated clinical research experience and/or study management/startup project manager experience
+ Demonstrated experience in managing country level operational activities and/or vendors
+ Experience in Study and Quality management and working in a matrix management environment
+ Expertise in the use of study/site dashboard and reporting tools
+ Detail oriented & possesses technical expertise
+ Ability to manage moderately complex processes
+ Ability to operate in a matrix environment
+ Risk Identification & Mitigation
+ Strategic Planning, Analytical and Problem-Solving Skills
+ Critical Path Analysis
+ Excellent communication skills, both written and verbal
+ Ability to adapt to changing technologies and processes
+ Effective verbal and written communication skills in relating to colleagues and associates
Nous recherchons actuellement un(e) Chef(fe) de Projet pour rejoindre notre équipe diversifiée et dynamique. En tant que Chef(fe) de Projet chez ICON, vous serez responsable de la direction et de la coordination des activités liées aux projets, en veillant à ce qu'ils soient livrés dans les délais, dans le respect du budget et selon les normes de qualité les plus élevées. Votre rôle consistera à superviser tous les aspects de l'exécution du projet, de la planification et de la gestion des ressources à la communication avec les parties prenantes et à la gestion des risques.
**Vos responsabilités :**
+ Responsable de la gestion/supervision des activités au niveau de l'étude ainsi qu'au niveau régional/pays, depuis le démarrage de l'étude jusqu'à sa conduite et sa clôture.
+ Peut gérer le processus de démarrage des études dans les pays assignés (lorsqu'aucun SUPM n'est désigné) et/ou superviser le pCRO responsable de ces activités, le cas échéant.
+ Par l'intermédiaire du Site Care Partner / Country Trial Manager ou du pCRO, soutient le processus de sensibilisation des pays/investigateurs, l'identification des sites et l'évaluation de faisabilité afin de garantir que les pays/sites peuvent répondre à toutes les exigences du protocole.
+ Fournit des contributions au niveau pays concernant les jalons de démarrage et de recrutement, tels que communiqués par le pCRO et/ou le Country Trial Manager / Site Care Partner au Global Study Manager lors de la planification.
+ Responsable de la supervision du pCRO et/ou du Country Trial Manager / Site Care Partner pour les études assignées au niveau pays, conformément au plan global du projet ; gère et maintient des plans précis au niveau pays (ex. : calendriers, budget, plans de risques et de qualité).
+ Collabore avec les rôles responsables pour identifier et gérer les écarts et risques lors du démarrage et de l'exécution des études et met en œuvre des stratégies d'atténuation si nécessaire. Responsable également de la résolution des escalades liées à l'activation des sites auprès des équipes d'étude, en proposant des options de mitigation.
+ Responsable de l'équipe locale d'étude (membres principaux : (Lead) Site Care Partner, Clinical Trial Assistant ; membres ad hoc : ICL, Site Activation Partner, CTRO, collègues des Affaires Réglementaires locales, Affaires Médicales et autres parties prenantes clés si nécessaire).
+ Garantit la conformité aux exigences et réglementations pertinentes, globales et locales, internes et externes.
+ Assure une communication bidirectionnelle et en temps opportun entre l'équipe globale et l'équipe locale d'étude.
+ Fournit des orientations et un soutien au niveau du protocole aux membres responsables de l'équipe locale d'étude, selon le cas.
+ Collabore avec le Site Care Partner, Lead Site Care Partner, Site Activation Partners et les collègues réglementaires du pays afin de convenir de la stratégie de soumission aux Autorités de Santé et aux Comités d'Éthique.
+ Utilise les rôles pays (ex. : Lead Site Care Partner) et les rôles experts (ex. : responsables contrats, Site Activation Partners) afin de fournir aux équipes globales des informations locales et des spécificités opérationnelles à prendre en compte.
+ Agit en tant que point de contact au niveau de l'étude pour toutes les questions de l'équipe locale d'étude, en assurant la résolution au niveau le plus approprié et, si nécessaire, en assurant l'escalade vers les équipes/global roles concernés.
+ Suit l'état des problématiques au niveau régional/pays afin de garantir leur résolution.
+ Identifie les tendances au niveau pays afin d'améliorer les processus de livrables si nécessaire.
+ Utilise les informations pays pour contribuer à l'identification des risques spécifiques pays dans le cadre de la préparation du Plan de Gestion de la Qualité Investigationnelle, des Plans de Monitoring d'Étude, assure l'exhaustivité du PTMF et la supervision des activités de conformité pertinentes pour les études allouées.
+ Assure la préparation aux audits/inspections pendant le démarrage et la conduite des études.
+ Gère les événements qualité applicables avec le pCRO et l'équipe locale, si nécessaire
+ Coordonne une planification efficace du recrutement des sites afin de permettre la mise en œuvre des plans au niveau pays et site, en cohérence avec le plan global et les objectifs locaux.
+ Responsable du pilotage et de la livraison des activités de nettoyage des données pour le pCRO et les sites, le cas échéant.
+ Fournit des contributions sur les coûts par sujet au niveau pays, les coûts des fournisseurs locaux et autres frais applicables.
+ Peut agir en tant qu'expert métier (Subject Matter Expert).
+ Peut diriger des initiatives d'efficacité opérationnelle au niveau pays ou régional.
+ Responsable de la revue des rapports PTA et SIV complétés par le Site Care Partner.
+ Soutient la mise en œuvre des systèmes technologiques du client pour les sites (ex. : Shared Investigator Platform (SIP), Centralized Account Management (CAM)).
+ Soutient les soumissions aux Comités d'Éthique/Autorités Réglementaires (EC/RA) et autres soumissions pertinentes (ex. : radiations, biobanques) ainsi que les réponses aux demandes d'informations/queries dans les délais requis pour les soumissions CTA initiales et ultérieures.
+ S'assure que le pCRO et/ou les membres internes de l'équipe d'étude mettent en place un PTMF conforme aux exigences de l'étude et en maintient la supervision.
+ Fournit les documents pays au PTMF et supervise la réconciliation et l'exhaustivité du Investigator Site File (ISF).
+ Veille à ce que le pCRO et/ou les membres internes de l'équipe gèrent de manière appropriée les produits investigués (IP), équipements et fournitures annexes, y compris la gestion des licences d'import/export, avec le soutien des Clinical Trial Assistants et autres rôles si nécessaire.
+ Soutient la mise en œuvre de nouveaux outils et technologies (ex. : eConsent, eISF, accès distant aux données sources, SDV/SDR à distance, iConnect, options d'essais décentralisés requises par le protocole, etc.).
+ Soutient l'identification, le développement contractuel et la gestion des fournisseurs ou établissements locaux conformément au protocole.
+ Soutient et gère les réunions investigateurs, y compris la réalisation de présentations si nécessaire.
+ Gère les réunions investigateurs locales, y compris la réalisation de présentations si nécessaire.
**Profil recherché :**
+ Diplôme scientifique ou technique souhaité, avec connaissance de la méthodologie des essais cliniques.
+ Diplôme BS/BSc/MS/MSc requis.
+ BA/BS avec 5+ ans d'expérience pertinente en opérations d'essais cliniques.
+ MBA/MS avec 3+ ans d'expérience pertinente en opérations d'essais cliniques.
+ Bonne connaissance des Bonnes Pratiques Cliniques (BPC/GCP), des opérations cliniques et réglementaires et de l'environnement réglementaire dans les pays sous responsabilité.
+ Expérience démontrée en recherche clinique et/ou en gestion d'étude / gestion de projets de démarrage d'étude.
+ Expérience démontrée dans la gestion d'activités opérationnelles au niveau pays et/ou de fournisseurs.
+ Expérience en gestion d'étude et gestion de la qualité dans un environnement matriciel.
+ Expertise dans l'utilisation d'outils de reporting et de tableaux de bord études/sites.
+ Sens du détail et expertise technique.
+ Capacité à gérer des processus modérément complexes.
+ Capacité à travailler dans un environnement matriciel.
+ Identification et mitigation des risques.
+ Compétences en planification stratégique, analyse et résolution de problèmes.
+ Analyse du chemin critique (Critical Path Analysis).
+ Excellentes compétences en communication écrite et orale.
+ Capacité à s'adapter aux évolutions technologiques et aux nouveaux processus.
+ Excellentes compétences relationnelles et rédactionnelles dans les échanges avec collègues et partenaires.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.
**What You Will Be Doing:**
+ Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
+ May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
+ Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
+ Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
+ Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
+ Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
+ Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
+ Ensures compliance to relevant Global and Local, internal and external requirements and regulations
+ Ensures timely communication bidirectionally between the global and local study team.
+ Provides protocol level guidance and support to responsible Local Study Team members as applicable.
+ Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
+ Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
+ Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
+ Follows up on region/country level issue status to ensure resolution.
+ Identifies country level trends to improve deliverables processes as needed
+ Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
+ Ensures audit/Inspection readiness during start-up and conduct
+ Manages applicable Quality Events with pCRO and local team as applicable and required
+ Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
+ Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
+ Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
+ May act as a Subject Matter Expert
+ May lead operational effectiveness initiatives at country or regional level
+ Responsible for PTA and SIV report review for reports completed by the Site Care Partner
+ Supports implementation of client's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
+ Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
+ Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
+ Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
+ Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
+ Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
+ Support Identification, contract development and management of local vendors or facilities as per protocol
+ Investigator Meeting support and management including doing presentations as appropriate
+ Management of local Investigator Meetings including doing presentations as appropriate
**What you need to have:**
+ A scientific or technical degree is preferred along with knowledge of clinical trial methodology
+ BS/BSc/MS/MSc degree required
+ BA/BS 5+ years of relevant experience operational clinical trial experience
+ MBA/MS/ 3+ years of relevant experience operational clinical trial experience
+ Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
+ Demonstrated clinical research experience and/or study management/startup project manager experience
+ Demonstrated experience in managing country level operational activities and/or vendors
+ Experience in Study and Quality management and working in a matrix management environment
+ Expertise in the use of study/site dashboard and reporting tools
+ Detail oriented & possesses technical expertise
+ Ability to manage moderately complex processes
+ Ability to operate in a matrix environment
+ Risk Identification & Mitigation
+ Strategic Planning, Analytical and Problem-Solving Skills
+ Critical Path Analysis
+ Excellent communication skills, both written and verbal
+ Ability to adapt to changing technologies and processes
+ Effective verbal and written communication skills in relating to colleagues and associates
Nous recherchons actuellement un(e) Chef(fe) de Projet pour rejoindre notre équipe diversifiée et dynamique. En tant que Chef(fe) de Projet chez ICON, vous serez responsable de la direction et de la coordination des activités liées aux projets, en veillant à ce qu'ils soient livrés dans les délais, dans le respect du budget et selon les normes de qualité les plus élevées. Votre rôle consistera à superviser tous les aspects de l'exécution du projet, de la planification et de la gestion des ressources à la communication avec les parties prenantes et à la gestion des risques.
**Vos responsabilités :**
+ Responsable de la gestion/supervision des activités au niveau de l'étude ainsi qu'au niveau régional/pays, depuis le démarrage de l'étude jusqu'à sa conduite et sa clôture.
+ Peut gérer le processus de démarrage des études dans les pays assignés (lorsqu'aucun SUPM n'est désigné) et/ou superviser le pCRO responsable de ces activités, le cas échéant.
+ Par l'intermédiaire du Site Care Partner / Country Trial Manager ou du pCRO, soutient le processus de sensibilisation des pays/investigateurs, l'identification des sites et l'évaluation de faisabilité afin de garantir que les pays/sites peuvent répondre à toutes les exigences du protocole.
+ Fournit des contributions au niveau pays concernant les jalons de démarrage et de recrutement, tels que communiqués par le pCRO et/ou le Country Trial Manager / Site Care Partner au Global Study Manager lors de la planification.
+ Responsable de la supervision du pCRO et/ou du Country Trial Manager / Site Care Partner pour les études assignées au niveau pays, conformément au plan global du projet ; gère et maintient des plans précis au niveau pays (ex. : calendriers, budget, plans de risques et de qualité).
+ Collabore avec les rôles responsables pour identifier et gérer les écarts et risques lors du démarrage et de l'exécution des études et met en œuvre des stratégies d'atténuation si nécessaire. Responsable également de la résolution des escalades liées à l'activation des sites auprès des équipes d'étude, en proposant des options de mitigation.
+ Responsable de l'équipe locale d'étude (membres principaux : (Lead) Site Care Partner, Clinical Trial Assistant ; membres ad hoc : ICL, Site Activation Partner, CTRO, collègues des Affaires Réglementaires locales, Affaires Médicales et autres parties prenantes clés si nécessaire).
+ Garantit la conformité aux exigences et réglementations pertinentes, globales et locales, internes et externes.
+ Assure une communication bidirectionnelle et en temps opportun entre l'équipe globale et l'équipe locale d'étude.
+ Fournit des orientations et un soutien au niveau du protocole aux membres responsables de l'équipe locale d'étude, selon le cas.
+ Collabore avec le Site Care Partner, Lead Site Care Partner, Site Activation Partners et les collègues réglementaires du pays afin de convenir de la stratégie de soumission aux Autorités de Santé et aux Comités d'Éthique.
+ Utilise les rôles pays (ex. : Lead Site Care Partner) et les rôles experts (ex. : responsables contrats, Site Activation Partners) afin de fournir aux équipes globales des informations locales et des spécificités opérationnelles à prendre en compte.
+ Agit en tant que point de contact au niveau de l'étude pour toutes les questions de l'équipe locale d'étude, en assurant la résolution au niveau le plus approprié et, si nécessaire, en assurant l'escalade vers les équipes/global roles concernés.
+ Suit l'état des problématiques au niveau régional/pays afin de garantir leur résolution.
+ Identifie les tendances au niveau pays afin d'améliorer les processus de livrables si nécessaire.
+ Utilise les informations pays pour contribuer à l'identification des risques spécifiques pays dans le cadre de la préparation du Plan de Gestion de la Qualité Investigationnelle, des Plans de Monitoring d'Étude, assure l'exhaustivité du PTMF et la supervision des activités de conformité pertinentes pour les études allouées.
+ Assure la préparation aux audits/inspections pendant le démarrage et la conduite des études.
+ Gère les événements qualité applicables avec le pCRO et l'équipe locale, si nécessaire
+ Coordonne une planification efficace du recrutement des sites afin de permettre la mise en œuvre des plans au niveau pays et site, en cohérence avec le plan global et les objectifs locaux.
+ Responsable du pilotage et de la livraison des activités de nettoyage des données pour le pCRO et les sites, le cas échéant.
+ Fournit des contributions sur les coûts par sujet au niveau pays, les coûts des fournisseurs locaux et autres frais applicables.
+ Peut agir en tant qu'expert métier (Subject Matter Expert).
+ Peut diriger des initiatives d'efficacité opérationnelle au niveau pays ou régional.
+ Responsable de la revue des rapports PTA et SIV complétés par le Site Care Partner.
+ Soutient la mise en œuvre des systèmes technologiques du client pour les sites (ex. : Shared Investigator Platform (SIP), Centralized Account Management (CAM)).
+ Soutient les soumissions aux Comités d'Éthique/Autorités Réglementaires (EC/RA) et autres soumissions pertinentes (ex. : radiations, biobanques) ainsi que les réponses aux demandes d'informations/queries dans les délais requis pour les soumissions CTA initiales et ultérieures.
+ S'assure que le pCRO et/ou les membres internes de l'équipe d'étude mettent en place un PTMF conforme aux exigences de l'étude et en maintient la supervision.
+ Fournit les documents pays au PTMF et supervise la réconciliation et l'exhaustivité du Investigator Site File (ISF).
+ Veille à ce que le pCRO et/ou les membres internes de l'équipe gèrent de manière appropriée les produits investigués (IP), équipements et fournitures annexes, y compris la gestion des licences d'import/export, avec le soutien des Clinical Trial Assistants et autres rôles si nécessaire.
+ Soutient la mise en œuvre de nouveaux outils et technologies (ex. : eConsent, eISF, accès distant aux données sources, SDV/SDR à distance, iConnect, options d'essais décentralisés requises par le protocole, etc.).
+ Soutient l'identification, le développement contractuel et la gestion des fournisseurs ou établissements locaux conformément au protocole.
+ Soutient et gère les réunions investigateurs, y compris la réalisation de présentations si nécessaire.
+ Gère les réunions investigateurs locales, y compris la réalisation de présentations si nécessaire.
**Profil recherché :**
+ Diplôme scientifique ou technique souhaité, avec connaissance de la méthodologie des essais cliniques.
+ Diplôme BS/BSc/MS/MSc requis.
+ BA/BS avec 5+ ans d'expérience pertinente en opérations d'essais cliniques.
+ MBA/MS avec 3+ ans d'expérience pertinente en opérations d'essais cliniques.
+ Bonne connaissance des Bonnes Pratiques Cliniques (BPC/GCP), des opérations cliniques et réglementaires et de l'environnement réglementaire dans les pays sous responsabilité.
+ Expérience démontrée en recherche clinique et/ou en gestion d'étude / gestion de projets de démarrage d'étude.
+ Expérience démontrée dans la gestion d'activités opérationnelles au niveau pays et/ou de fournisseurs.
+ Expérience en gestion d'étude et gestion de la qualité dans un environnement matriciel.
+ Expertise dans l'utilisation d'outils de reporting et de tableaux de bord études/sites.
+ Sens du détail et expertise technique.
+ Capacité à gérer des processus modérément complexes.
+ Capacité à travailler dans un environnement matriciel.
+ Identification et mitigation des risques.
+ Compétences en planification stratégique, analyse et résolution de problèmes.
+ Analyse du chemin critique (Critical Path Analysis).
+ Excellentes compétences en communication écrite et orale.
+ Capacité à s'adapter aux évolutions technologiques et aux nouveaux processus.
+ Excellentes compétences relationnelles et rédactionnelles dans les échanges avec collègues et partenaires.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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2
Job Description
Study Start Up Associate I - Montréal, Canada-Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a **_Study Start Up Associate II_** to join our diverse and dynamic team. **_As a Study Start Up Associate II at ICON,_** you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNovative treatments and therapies.
**What you will be doing**
+ Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
+ Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
+ Maintaining accurate and up-to-date records of regulatory submissions and approvals.
+ Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
+ Participating in study start-up meetings and providing input on regulatory requirements and timelines.
**Your profile**
+ Bachelor's degree in life sciences or a related field.Previous experience in clinical research or regulatory affairs is preferred.
+ 1+ years of Study Start-Up (SSU) experience.
+ Strong attention to detail and organizational skills.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
+ Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
+ Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications.
Nous recherchons actuellement un(e) **Associate II, Démarrage d'Étude (Study Start Up Associate II)** pour rejoindre notre équipe diversifiée et dynamique. **_En tant qu Associate II, Démarrage d'Étude chez ICON,_** vous jouerez un rôle clé dans la mise en place des essais cliniques, en veillant au respect des exigences réglementaires et en contribuant à l'avancement de traitements et thérapies innovants.
**Vos principales responsabilités**
+ Participer à la préparation et à la soumission des documents réglementaires, tels que les demandes d'essais cliniques et les soumissions aux comités d'éthique.
+ Plus de 1 an d'expérience en démarrage d'études cliniques (SSU).
+ Coordonner avec les parties prenantes internes et externes pour obtenir les autorisations et approbations nécessaires au lancement des études.
+ Maintenir des registres précis et à jour des soumissions et des approbations réglementaires.
+ Soutenir les équipes d'étude dans l'élaboration des documents d'étude, y compris les protocoles, les formulaires de consentement éclairé et les brochures des investigateurs.
+ Participer aux réunions de démarrage d'étude et fournir des conseils sur les exigences réglementaires et les délais.
**Votre profil**
+ Diplôme de licence (baccalauréat) en sciences de la vie ou dans un domaine connexe.
+ Une expérience préalable en recherche clinique ou en affaires réglementaires est un atout.
+ Excellente attention aux détails et solides compétences organisationnelles.
+ Excellentes compétences en communication et en relations interpersonnelles, avec la capacité de collaborer efficacement au sein d'équipes interdisciplinaires.
+ Capacité à travailler de manière autonome et à gérer plusieurs tâches simultanément dans un environnement dynamique.
+ Compétences avancées en communication en français, incluant une aisance orale fluide et une excellente maîtrise écrite pour les documents d'étude et les communications réglementaires.
\#LI-JG1 #LI-Remote
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a **_Study Start Up Associate II_** to join our diverse and dynamic team. **_As a Study Start Up Associate II at ICON,_** you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNovative treatments and therapies.
**What you will be doing**
+ Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
+ Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
+ Maintaining accurate and up-to-date records of regulatory submissions and approvals.
+ Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
+ Participating in study start-up meetings and providing input on regulatory requirements and timelines.
**Your profile**
+ Bachelor's degree in life sciences or a related field.Previous experience in clinical research or regulatory affairs is preferred.
+ 1+ years of Study Start-Up (SSU) experience.
+ Strong attention to detail and organizational skills.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
+ Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
+ Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications.
Nous recherchons actuellement un(e) **Associate II, Démarrage d'Étude (Study Start Up Associate II)** pour rejoindre notre équipe diversifiée et dynamique. **_En tant qu Associate II, Démarrage d'Étude chez ICON,_** vous jouerez un rôle clé dans la mise en place des essais cliniques, en veillant au respect des exigences réglementaires et en contribuant à l'avancement de traitements et thérapies innovants.
**Vos principales responsabilités**
+ Participer à la préparation et à la soumission des documents réglementaires, tels que les demandes d'essais cliniques et les soumissions aux comités d'éthique.
+ Plus de 1 an d'expérience en démarrage d'études cliniques (SSU).
+ Coordonner avec les parties prenantes internes et externes pour obtenir les autorisations et approbations nécessaires au lancement des études.
+ Maintenir des registres précis et à jour des soumissions et des approbations réglementaires.
+ Soutenir les équipes d'étude dans l'élaboration des documents d'étude, y compris les protocoles, les formulaires de consentement éclairé et les brochures des investigateurs.
+ Participer aux réunions de démarrage d'étude et fournir des conseils sur les exigences réglementaires et les délais.
**Votre profil**
+ Diplôme de licence (baccalauréat) en sciences de la vie ou dans un domaine connexe.
+ Une expérience préalable en recherche clinique ou en affaires réglementaires est un atout.
+ Excellente attention aux détails et solides compétences organisationnelles.
+ Excellentes compétences en communication et en relations interpersonnelles, avec la capacité de collaborer efficacement au sein d'équipes interdisciplinaires.
+ Capacité à travailler de manière autonome et à gérer plusieurs tâches simultanément dans un environnement dynamique.
+ Compétences avancées en communication en français, incluant une aisance orale fluide et une excellente maîtrise écrite pour les documents d'étude et les communications réglementaires.
\#LI-JG1 #LI-Remote
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
Is this job a match or a miss?
Apply Now
3
Job Description
Global Study Manager
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Senior Project Manager at ICON, you will be responsible for leading and manage projects, ensuring successful execution and delivery of project objectives.
**What You Will Do:**
You will manage day-to-day project and programme management activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
+ Developing and executing project plans, focusing on achieving project goals and objectives.
+ Leading cross-functional teams to ensure the successful implementation of project activities.
+ Collaborating with stakeholders to identify project requirements and define project scope.
+ Mentoring and guiding team members, fostering a culture of excellence and continuous improvement.
+ Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner.
+ Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies.
+ Contributing to organizational growth through effective project leadership and strategic planning.
**Your Profile:**
You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
+ Bachelor's degree in a relevant scientific discipline or healthcare-related field
+ Extensive experience in project management, with a proven track record of leading successful projects in the pharmaceutical or biotech industry.
+ Strong proficiency in project management tools and methodologies, with excellent attention to detail.
+ Excellent analytical and problem-solving skills, with the ability to develop effective project strategies.
+ Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
+ Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
+ Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.
+ Willingness to travel as required (approximately 25%)
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Senior Project Manager at ICON, you will be responsible for leading and manage projects, ensuring successful execution and delivery of project objectives.
**What You Will Do:**
You will manage day-to-day project and programme management activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
+ Developing and executing project plans, focusing on achieving project goals and objectives.
+ Leading cross-functional teams to ensure the successful implementation of project activities.
+ Collaborating with stakeholders to identify project requirements and define project scope.
+ Mentoring and guiding team members, fostering a culture of excellence and continuous improvement.
+ Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner.
+ Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies.
+ Contributing to organizational growth through effective project leadership and strategic planning.
**Your Profile:**
You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
+ Bachelor's degree in a relevant scientific discipline or healthcare-related field
+ Extensive experience in project management, with a proven track record of leading successful projects in the pharmaceutical or biotech industry.
+ Strong proficiency in project management tools and methodologies, with excellent attention to detail.
+ Excellent analytical and problem-solving skills, with the ability to develop effective project strategies.
+ Demonstrated leadership skills, with experience in managing and mentoring teams effectively.
+ Exceptional communication skills, with the ability to convey technical concepts to diverse audiences.
+ Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.
+ Willingness to travel as required (approximately 25%)
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
Is this job a match or a miss?
Apply Now
4
Job Description
Country Study Operations Manager- Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.
**What You Will Be Doing:**
+ Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
+ May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
+ Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
+ Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
+ Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
+ Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
+ Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
+ Ensures compliance to relevant Global and Local, internal and external requirements and regulations
+ Ensures timely communication bidirectionally between the global and local study team.
+ Provides protocol level guidance and support to responsible Local Study Team members as applicable.
+ Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
+ Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
+ Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
+ Follows up on region/country level issue status to ensure resolution.
+ Identifies country level trends to improve deliverables processes as needed
+ Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
+ Ensures audit/Inspection readiness during start-up and conduct
+ Manages applicable Quality Events with pCRO and local team as applicable and required
+ Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
+ Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
+ Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
+ May act as a Subject Matter Expert
+ May lead operational effectiveness initiatives at country or regional level
+ Responsible for PTA and SIV report review for reports completed by the Site Care Partner
+ Supports implementation of client's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
+ Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
+ Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
+ Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
+ Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
+ Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
+ Support Identification, contract development and management of local vendors or facilities as per protocol
+ Investigator Meeting support and management including doing presentations as appropriate
+ Management of local Investigator Meetings including doing presentations as appropriate
**What you need to have:**
+ A scientific or technical degree is preferred along with knowledge of clinical trial methodology
+ BS/BSc/MS/MSc degree required
+ BA/BS 5+ years of relevant experience operational clinical trial experience
+ MBA/MS/ 3+ years of relevant experience operational clinical trial experience
+ Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
+ Demonstrated clinical research experience and/or study management/startup project manager experience
+ Demonstrated experience in managing country level operational activities and/or vendors
+ Experience in Study and Quality management and working in a matrix management environment
+ Expertise in the use of study/site dashboard and reporting tools
+ Detail oriented & possesses technical expertise
+ Ability to manage moderately complex processes
+ Ability to operate in a matrix environment
+ Risk Identification & Mitigation
+ Strategic Planning, Analytical and Problem-Solving Skills
+ Critical Path Analysis
+ Excellent communication skills, both written and verbal
+ Ability to adapt to changing technologies and processes
+ Effective verbal and written communication skills in relating to colleagues and associates
Nous recherchons actuellement un(e) **Chef(fe) de Projet** pour rejoindre notre équipe diversifiée et dynamique. En tant que Chef(fe) de Projet chez ICON, vous serez responsable de la direction et de la coordination des activités liées aux projets, en veillant à ce qu'ils soient livrés dans les délais, dans le respect du budget et selon les normes de qualité les plus élevées. Votre rôle consistera à superviser tous les aspects de l'exécution du projet, de la planification et de la gestion des ressources à la communication avec les parties prenantes et à la gestion des risques.
**Vos responsabilités :**
+ Responsable de la gestion/supervision des activités au niveau de l'étude ainsi qu'au niveau régional/pays, depuis le démarrage de l'étude jusqu'à sa conduite et sa clôture.
+ Peut gérer le processus de démarrage des études dans les pays assignés (lorsqu'aucun SUPM n'est désigné) et/ou superviser le pCRO responsable de ces activités, le cas échéant.
+ Par l'intermédiaire du Site Care Partner / Country Trial Manager ou du pCRO, soutient le processus de sensibilisation des pays/investigateurs, l'identification des sites et l'évaluation de faisabilité afin de garantir que les pays/sites peuvent répondre à toutes les exigences du protocole.
+ Fournit des contributions au niveau pays concernant les jalons de démarrage et de recrutement, tels que communiqués par le pCRO et/ou le Country Trial Manager / Site Care Partner au Global Study Manager lors de la planification.
+ Responsable de la supervision du pCRO et/ou du Country Trial Manager / Site Care Partner pour les études assignées au niveau pays, conformément au plan global du projet ; gère et maintient des plans précis au niveau pays (ex. : calendriers, budget, plans de risques et de qualité).
+ Collabore avec les rôles responsables pour identifier et gérer les écarts et risques lors du démarrage et de l'exécution des études et met en œuvre des stratégies d'atténuation si nécessaire. Responsable également de la résolution des escalades liées à l'activation des sites auprès des équipes d'étude, en proposant des options de mitigation.
+ Responsable de l'équipe locale d'étude (membres principaux : (Lead) Site Care Partner, Clinical Trial Assistant ; membres ad hoc : ICL, Site Activation Partner, CTRO, collègues des Affaires Réglementaires locales, Affaires Médicales et autres parties prenantes clés si nécessaire).
+ Garantit la conformité aux exigences et réglementations pertinentes, globales et locales, internes et externes.
+ Assure une communication bidirectionnelle et en temps opportun entre l'équipe globale et l'équipe locale d'étude.
+ Fournit des orientations et un soutien au niveau du protocole aux membres responsables de l'équipe locale d'étude, selon le cas.
+ Collabore avec le Site Care Partner, Lead Site Care Partner, Site Activation Partners et les collègues réglementaires du pays afin de convenir de la stratégie de soumission aux Autorités de Santé et aux Comités d'Éthique.
+ Utilise les rôles pays (ex. : Lead Site Care Partner) et les rôles experts (ex. : responsables contrats, Site Activation Partners) afin de fournir aux équipes globales des informations locales et des spécificités opérationnelles à prendre en compte.
+ Agit en tant que point de contact au niveau de l'étude pour toutes les questions de l'équipe locale d'étude, en assurant la résolution au niveau le plus approprié et, si nécessaire, en assurant l'escalade vers les équipes/global roles concernés.
+ Suit l'état des problématiques au niveau régional/pays afin de garantir leur résolution.
+ Identifie les tendances au niveau pays afin d'améliorer les processus de livrables si nécessaire.
+ Utilise les informations pays pour contribuer à l'identification des risques spécifiques pays dans le cadre de la préparation du Plan de Gestion de la Qualité Investigationnelle, des Plans de Monitoring d'Étude, assure l'exhaustivité du PTMF et la supervision des activités de conformité pertinentes pour les études allouées.
+ Assure la préparation aux audits/inspections pendant le démarrage et la conduite des études.
+ Gère les événements qualité applicables avec le pCRO et l'équipe locale, si nécessaire.
+ Coordonne une planification efficace du recrutement des sites afin de permettre la mise en œuvre des plans au niveau pays et site, en cohérence avec le plan global et les objectifs locaux.
+ Responsable du pilotage et de la livraison des activités de nettoyage des données pour le pCRO et les sites, le cas échéant.
+ Fournit des contributions sur les coûts par sujet au niveau pays, les coûts des fournisseurs locaux et autres frais applicables.
+ Peut agir en tant qu'expert métier (Subject Matter Expert).
+ Peut diriger des initiatives d'efficacité opérationnelle au niveau pays ou régional.
+ Responsable de la revue des rapports PTA et SIV complétés par le Site Care Partner.
+ Soutient la mise en œuvre des systèmes technologiques du client pour les sites (ex. : Shared Investigator Platform (SIP), Centralized Account Management (CAM)).
+ Soutient les soumissions aux Comités d'Éthique/Autorités Réglementaires (EC/RA) et autres soumissions pertinentes (ex. : radiations, biobanques) ainsi que les réponses aux demandes d'informations/queries dans les délais requis pour les soumissions CTA initiales et ultérieures.
+ S'assure que le pCRO et/ou les membres internes de l'équipe d'étude mettent en place un PTMF conforme aux exigences de l'étude et en maintient la supervision.
+ Fournit les documents pays au PTMF et supervise la réconciliation et l'exhaustivité du Investigator Site File (ISF).
+ Veille à ce que le pCRO et/ou les membres internes de l'équipe gèrent de manière appropriée les produits investigués (IP), équipements et fournitures annexes, y compris la gestion des licences d'import/export, avec le soutien des Clinical Trial Assistants et autres rôles si nécessaire.
+ Soutient la mise en œuvre de nouveaux outils et technologies (ex. : eConsent, eISF, accès distant aux données sources, SDV/SDR à distance, iConnect, options d'essais décentralisés requises par le protocole, etc.).
+ Soutient l'identification, le développement contractuel et la gestion des fournisseurs ou établissements locaux conformément au protocole.
+ Soutient et gère les réunions investigateurs, y compris la réalisation de présentations si nécessaire.
+ Gère les réunions investigateurs locales, y compris la réalisation de présentations si nécessaire.
**Profil recherché :**
+ Diplôme scientifique ou technique souhaité, avec connaissance de la méthodologie des essais cliniques.
+ Diplôme BS/BSc/MS/MSc requis.
+ BA/BS avec 5+ ans d'expérience pertinente en opérations d'essais cliniques.
+ MBA/MS avec 3+ ans d'expérience pertinente en opérations d'essais cliniques.
+ Bonne connaissance des Bonnes Pratiques Cliniques (BPC/GCP), des opérations cliniques et réglementaires et de l'environnement réglementaire dans les pays sous responsabilité.
+ Expérience démontrée en recherche clinique et/ou en gestion d'étude / gestion de projets de démarrage d'étude.
+ Expérience démontrée dans la gestion d'activités opérationnelles au niveau pays et/ou de fournisseurs.
+ Expérience en gestion d'étude et gestion de la qualité dans un environnement matriciel.
+ Expertise dans l'utilisation d'outils de reporting et de tableaux de bord études/sites.
+ Sens du détail et expertise technique.
+ Capacité à gérer des processus modérément complexes.
+ Capacité à travailler dans un environnement matriciel.
+ Identification et mitigation des risques.
+ Compétences en planification stratégique, analyse et résolution de problèmes.
+ Analyse du chemin critique (Critical Path Analysis).
+ Excellentes compétences en communication écrite et orale.
+ Capacité à s'adapter aux évolutions technologiques et aux nouveaux processus.
+ Excellentes compétences relationnelles et rédactionnelles dans les échanges avec collègues et partenaires.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.
**What You Will Be Doing:**
+ Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
+ May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
+ Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
+ Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
+ Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
+ Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
+ Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
+ Ensures compliance to relevant Global and Local, internal and external requirements and regulations
+ Ensures timely communication bidirectionally between the global and local study team.
+ Provides protocol level guidance and support to responsible Local Study Team members as applicable.
+ Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
+ Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
+ Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
+ Follows up on region/country level issue status to ensure resolution.
+ Identifies country level trends to improve deliverables processes as needed
+ Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
+ Ensures audit/Inspection readiness during start-up and conduct
+ Manages applicable Quality Events with pCRO and local team as applicable and required
+ Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
+ Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
+ Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
+ May act as a Subject Matter Expert
+ May lead operational effectiveness initiatives at country or regional level
+ Responsible for PTA and SIV report review for reports completed by the Site Care Partner
+ Supports implementation of client's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
+ Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
+ Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
+ Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
+ Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
+ Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
+ Support Identification, contract development and management of local vendors or facilities as per protocol
+ Investigator Meeting support and management including doing presentations as appropriate
+ Management of local Investigator Meetings including doing presentations as appropriate
**What you need to have:**
+ A scientific or technical degree is preferred along with knowledge of clinical trial methodology
+ BS/BSc/MS/MSc degree required
+ BA/BS 5+ years of relevant experience operational clinical trial experience
+ MBA/MS/ 3+ years of relevant experience operational clinical trial experience
+ Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
+ Demonstrated clinical research experience and/or study management/startup project manager experience
+ Demonstrated experience in managing country level operational activities and/or vendors
+ Experience in Study and Quality management and working in a matrix management environment
+ Expertise in the use of study/site dashboard and reporting tools
+ Detail oriented & possesses technical expertise
+ Ability to manage moderately complex processes
+ Ability to operate in a matrix environment
+ Risk Identification & Mitigation
+ Strategic Planning, Analytical and Problem-Solving Skills
+ Critical Path Analysis
+ Excellent communication skills, both written and verbal
+ Ability to adapt to changing technologies and processes
+ Effective verbal and written communication skills in relating to colleagues and associates
Nous recherchons actuellement un(e) **Chef(fe) de Projet** pour rejoindre notre équipe diversifiée et dynamique. En tant que Chef(fe) de Projet chez ICON, vous serez responsable de la direction et de la coordination des activités liées aux projets, en veillant à ce qu'ils soient livrés dans les délais, dans le respect du budget et selon les normes de qualité les plus élevées. Votre rôle consistera à superviser tous les aspects de l'exécution du projet, de la planification et de la gestion des ressources à la communication avec les parties prenantes et à la gestion des risques.
**Vos responsabilités :**
+ Responsable de la gestion/supervision des activités au niveau de l'étude ainsi qu'au niveau régional/pays, depuis le démarrage de l'étude jusqu'à sa conduite et sa clôture.
+ Peut gérer le processus de démarrage des études dans les pays assignés (lorsqu'aucun SUPM n'est désigné) et/ou superviser le pCRO responsable de ces activités, le cas échéant.
+ Par l'intermédiaire du Site Care Partner / Country Trial Manager ou du pCRO, soutient le processus de sensibilisation des pays/investigateurs, l'identification des sites et l'évaluation de faisabilité afin de garantir que les pays/sites peuvent répondre à toutes les exigences du protocole.
+ Fournit des contributions au niveau pays concernant les jalons de démarrage et de recrutement, tels que communiqués par le pCRO et/ou le Country Trial Manager / Site Care Partner au Global Study Manager lors de la planification.
+ Responsable de la supervision du pCRO et/ou du Country Trial Manager / Site Care Partner pour les études assignées au niveau pays, conformément au plan global du projet ; gère et maintient des plans précis au niveau pays (ex. : calendriers, budget, plans de risques et de qualité).
+ Collabore avec les rôles responsables pour identifier et gérer les écarts et risques lors du démarrage et de l'exécution des études et met en œuvre des stratégies d'atténuation si nécessaire. Responsable également de la résolution des escalades liées à l'activation des sites auprès des équipes d'étude, en proposant des options de mitigation.
+ Responsable de l'équipe locale d'étude (membres principaux : (Lead) Site Care Partner, Clinical Trial Assistant ; membres ad hoc : ICL, Site Activation Partner, CTRO, collègues des Affaires Réglementaires locales, Affaires Médicales et autres parties prenantes clés si nécessaire).
+ Garantit la conformité aux exigences et réglementations pertinentes, globales et locales, internes et externes.
+ Assure une communication bidirectionnelle et en temps opportun entre l'équipe globale et l'équipe locale d'étude.
+ Fournit des orientations et un soutien au niveau du protocole aux membres responsables de l'équipe locale d'étude, selon le cas.
+ Collabore avec le Site Care Partner, Lead Site Care Partner, Site Activation Partners et les collègues réglementaires du pays afin de convenir de la stratégie de soumission aux Autorités de Santé et aux Comités d'Éthique.
+ Utilise les rôles pays (ex. : Lead Site Care Partner) et les rôles experts (ex. : responsables contrats, Site Activation Partners) afin de fournir aux équipes globales des informations locales et des spécificités opérationnelles à prendre en compte.
+ Agit en tant que point de contact au niveau de l'étude pour toutes les questions de l'équipe locale d'étude, en assurant la résolution au niveau le plus approprié et, si nécessaire, en assurant l'escalade vers les équipes/global roles concernés.
+ Suit l'état des problématiques au niveau régional/pays afin de garantir leur résolution.
+ Identifie les tendances au niveau pays afin d'améliorer les processus de livrables si nécessaire.
+ Utilise les informations pays pour contribuer à l'identification des risques spécifiques pays dans le cadre de la préparation du Plan de Gestion de la Qualité Investigationnelle, des Plans de Monitoring d'Étude, assure l'exhaustivité du PTMF et la supervision des activités de conformité pertinentes pour les études allouées.
+ Assure la préparation aux audits/inspections pendant le démarrage et la conduite des études.
+ Gère les événements qualité applicables avec le pCRO et l'équipe locale, si nécessaire.
+ Coordonne une planification efficace du recrutement des sites afin de permettre la mise en œuvre des plans au niveau pays et site, en cohérence avec le plan global et les objectifs locaux.
+ Responsable du pilotage et de la livraison des activités de nettoyage des données pour le pCRO et les sites, le cas échéant.
+ Fournit des contributions sur les coûts par sujet au niveau pays, les coûts des fournisseurs locaux et autres frais applicables.
+ Peut agir en tant qu'expert métier (Subject Matter Expert).
+ Peut diriger des initiatives d'efficacité opérationnelle au niveau pays ou régional.
+ Responsable de la revue des rapports PTA et SIV complétés par le Site Care Partner.
+ Soutient la mise en œuvre des systèmes technologiques du client pour les sites (ex. : Shared Investigator Platform (SIP), Centralized Account Management (CAM)).
+ Soutient les soumissions aux Comités d'Éthique/Autorités Réglementaires (EC/RA) et autres soumissions pertinentes (ex. : radiations, biobanques) ainsi que les réponses aux demandes d'informations/queries dans les délais requis pour les soumissions CTA initiales et ultérieures.
+ S'assure que le pCRO et/ou les membres internes de l'équipe d'étude mettent en place un PTMF conforme aux exigences de l'étude et en maintient la supervision.
+ Fournit les documents pays au PTMF et supervise la réconciliation et l'exhaustivité du Investigator Site File (ISF).
+ Veille à ce que le pCRO et/ou les membres internes de l'équipe gèrent de manière appropriée les produits investigués (IP), équipements et fournitures annexes, y compris la gestion des licences d'import/export, avec le soutien des Clinical Trial Assistants et autres rôles si nécessaire.
+ Soutient la mise en œuvre de nouveaux outils et technologies (ex. : eConsent, eISF, accès distant aux données sources, SDV/SDR à distance, iConnect, options d'essais décentralisés requises par le protocole, etc.).
+ Soutient l'identification, le développement contractuel et la gestion des fournisseurs ou établissements locaux conformément au protocole.
+ Soutient et gère les réunions investigateurs, y compris la réalisation de présentations si nécessaire.
+ Gère les réunions investigateurs locales, y compris la réalisation de présentations si nécessaire.
**Profil recherché :**
+ Diplôme scientifique ou technique souhaité, avec connaissance de la méthodologie des essais cliniques.
+ Diplôme BS/BSc/MS/MSc requis.
+ BA/BS avec 5+ ans d'expérience pertinente en opérations d'essais cliniques.
+ MBA/MS avec 3+ ans d'expérience pertinente en opérations d'essais cliniques.
+ Bonne connaissance des Bonnes Pratiques Cliniques (BPC/GCP), des opérations cliniques et réglementaires et de l'environnement réglementaire dans les pays sous responsabilité.
+ Expérience démontrée en recherche clinique et/ou en gestion d'étude / gestion de projets de démarrage d'étude.
+ Expérience démontrée dans la gestion d'activités opérationnelles au niveau pays et/ou de fournisseurs.
+ Expérience en gestion d'étude et gestion de la qualité dans un environnement matriciel.
+ Expertise dans l'utilisation d'outils de reporting et de tableaux de bord études/sites.
+ Sens du détail et expertise technique.
+ Capacité à gérer des processus modérément complexes.
+ Capacité à travailler dans un environnement matriciel.
+ Identification et mitigation des risques.
+ Compétences en planification stratégique, analyse et résolution de problèmes.
+ Analyse du chemin critique (Critical Path Analysis).
+ Excellentes compétences en communication écrite et orale.
+ Capacité à s'adapter aux évolutions technologiques et aux nouveaux processus.
+ Excellentes compétences relationnelles et rédactionnelles dans les échanges avec collègues et partenaires.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
Is this job a match or a miss?
Apply Now
5
Job Description
**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
AECOM is seeking a **Risk Assessment Discipline Lead** to join our Canada Remediation team. This leadership role is responsible for driving technical excellence, innovation, and consistency in human health and ecological risk assessment practices across projects in Canada.
You will serve as a subject matter expert, mentor junior and senior staff, and collaborate with multidisciplinary teams to deliver high-quality, defensible risk assessments that support site remediation and regulatory compliance.
**Job Description**
AECOM is seeking a **Risk Assessment Discipline Lead** to join our Canada Remediation team. This leadership role is responsible for driving technical excellence, innovation, and consistency in human health and ecological risk assessment practices across projects in Canada.
You will serve as a subject matter expert, mentor junior and senior staff, and collaborate with multidisciplinary teams to deliver high-quality, defensible risk assessments that support site remediation and regulatory compliance.
**Team Leadership and Growth**
+ Build and mentor a high-performing team of technical staff across multiple Canada offices.
+ Provide coaching, training, and leadership for junior, mid-level and senior risk assessors.
+ Foster cross-functional teamwork, ensuring alignment between toxicologists, ecologists, biologists, project managers, remediation engineers, and other stakeholders.
+ Drive professional development within team.
+ Promote collaboration, innovation, and technical excellence across projects.
+ Provide strategic proposals and budgets in support of risk assessment tasks for new work opportunities.
+ Drive professional development within team.
**Project Delivery & Management**
+ Lead full lifecycle project delivery-from preliminary screening to complete risk assessment.
+ Manage budgets, schedules, resources, and client communications.
+ Ensure quality and compliance with regulatory and environmental standards.
+ Translate complex risk findings into clear, actionable communication for regulators, clients, and internal stakeholders.
+ Execution and reporting of Human Health and Ecological Risk Assessments for a variety of client types for risk-based management of contaminated sites across Canada.
+ Execution and reporting of Human Health and Ecological Risk Assessments for new Canadian projects subject to environment impact assessment legislation, and support as expert witness in the approval process.
+ Work with AECOM project managers and Canadian Risk Assessment Team to develop site-specific risk management strategies that will include the development of both technical approach and estimating costs.
+ Regularly communicate with regulators, clients, and other AECOM technical staff/project managers.
**Technical Expertise**
+ Have demonstrated knowledge and competencies in risk assessment as it relates to human health including First Nations, ecological health, air, water, groundwater, soil, soil vapour, sediment, porewater, foodchains, and contaminant fate and transport, statistics, and sampling design.
+ Maintain a working knowledge of risk-based regulations both federally and for one or more of the following Atlantic Canada, Ontario, Manitoba, Saskatchewan, Alberta, BC, Nunavut or Canadian Territories and conduct presentations on regulatory changes to other technical teams on an as-needed basis.
+ Apply regulatory risk assessment guidance across Canada (human health and ecological), including constructing conceptual site models and assessing exposure pathways.
+ For ecological assessments, design and interpret toxicity and bioaccumulation studies, determine media-specific screening criteria, etc.
+ For human health, evaluate exposure scenarios, dose-response and hazard characterization, and integrate emerging contaminants into risk assessments.
+ Strong understanding of toxicological foundations of risk assessment.
**Business Development**
+ Engage with clients to cultivate relationships and win new work.
+ Lead and support proposal development and client presentations, contributing technical insight to secure new work and expanding service lines
+ Contribute to business development opportunities across Canada that would benefit from a risk-based remediation approach.
**Strategic Planning & Innovation**
+ Develop service strategies, capitalize on market developments, and guide technical direction.
**Qualifications**
**Minimum Requirements**
The selected candidate will have the following qualifications, at a minimum:
+ B.Sc. in Toxicology, Environmental Science, Ecology, Public Health, or related discipline; Master's or Ph.D. is preferred
+ Professional designation in a Canadian province.
+ 10+ years in risk assessment consulting.
+ Track record of managing risk assessment from inception to completion.
**Preferred Qualifications**
+ Proficiency in practical, minimal credible scope development.
+ Strong project and personnel management capabilities.
+ Aptitude for strategic and business-focused thinking.
+ Strong technical writing skills for regulatory submittals and peer-reviewed reports.
+ Effective oral communication and stakeholder engagement capabilities
+ Valid Driver's License.
**Additional Information**
**Additional Information**
At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously. **_To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment._**
Offered rate of compensation will be based on individual education, qualifications, experience, and work location. The range for this position is $ to $ .
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines. Artificial intelligence will be used to support the screening, assessment, and selection of applicants for this role. Final hiring decisions are made by the hiring team.
**ReqID:** J
**Business Line:** Environment
**Business Group:** DCS
**Strategic Business Unit:** Canada
**Career Area:** Science
**Work Location Model:** Hybrid
**Compensation:** CAD - CAD - yearly
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
AECOM is seeking a **Risk Assessment Discipline Lead** to join our Canada Remediation team. This leadership role is responsible for driving technical excellence, innovation, and consistency in human health and ecological risk assessment practices across projects in Canada.
You will serve as a subject matter expert, mentor junior and senior staff, and collaborate with multidisciplinary teams to deliver high-quality, defensible risk assessments that support site remediation and regulatory compliance.
**Job Description**
AECOM is seeking a **Risk Assessment Discipline Lead** to join our Canada Remediation team. This leadership role is responsible for driving technical excellence, innovation, and consistency in human health and ecological risk assessment practices across projects in Canada.
You will serve as a subject matter expert, mentor junior and senior staff, and collaborate with multidisciplinary teams to deliver high-quality, defensible risk assessments that support site remediation and regulatory compliance.
**Team Leadership and Growth**
+ Build and mentor a high-performing team of technical staff across multiple Canada offices.
+ Provide coaching, training, and leadership for junior, mid-level and senior risk assessors.
+ Foster cross-functional teamwork, ensuring alignment between toxicologists, ecologists, biologists, project managers, remediation engineers, and other stakeholders.
+ Drive professional development within team.
+ Promote collaboration, innovation, and technical excellence across projects.
+ Provide strategic proposals and budgets in support of risk assessment tasks for new work opportunities.
+ Drive professional development within team.
**Project Delivery & Management**
+ Lead full lifecycle project delivery-from preliminary screening to complete risk assessment.
+ Manage budgets, schedules, resources, and client communications.
+ Ensure quality and compliance with regulatory and environmental standards.
+ Translate complex risk findings into clear, actionable communication for regulators, clients, and internal stakeholders.
+ Execution and reporting of Human Health and Ecological Risk Assessments for a variety of client types for risk-based management of contaminated sites across Canada.
+ Execution and reporting of Human Health and Ecological Risk Assessments for new Canadian projects subject to environment impact assessment legislation, and support as expert witness in the approval process.
+ Work with AECOM project managers and Canadian Risk Assessment Team to develop site-specific risk management strategies that will include the development of both technical approach and estimating costs.
+ Regularly communicate with regulators, clients, and other AECOM technical staff/project managers.
**Technical Expertise**
+ Have demonstrated knowledge and competencies in risk assessment as it relates to human health including First Nations, ecological health, air, water, groundwater, soil, soil vapour, sediment, porewater, foodchains, and contaminant fate and transport, statistics, and sampling design.
+ Maintain a working knowledge of risk-based regulations both federally and for one or more of the following Atlantic Canada, Ontario, Manitoba, Saskatchewan, Alberta, BC, Nunavut or Canadian Territories and conduct presentations on regulatory changes to other technical teams on an as-needed basis.
+ Apply regulatory risk assessment guidance across Canada (human health and ecological), including constructing conceptual site models and assessing exposure pathways.
+ For ecological assessments, design and interpret toxicity and bioaccumulation studies, determine media-specific screening criteria, etc.
+ For human health, evaluate exposure scenarios, dose-response and hazard characterization, and integrate emerging contaminants into risk assessments.
+ Strong understanding of toxicological foundations of risk assessment.
**Business Development**
+ Engage with clients to cultivate relationships and win new work.
+ Lead and support proposal development and client presentations, contributing technical insight to secure new work and expanding service lines
+ Contribute to business development opportunities across Canada that would benefit from a risk-based remediation approach.
**Strategic Planning & Innovation**
+ Develop service strategies, capitalize on market developments, and guide technical direction.
**Qualifications**
**Minimum Requirements**
The selected candidate will have the following qualifications, at a minimum:
+ B.Sc. in Toxicology, Environmental Science, Ecology, Public Health, or related discipline; Master's or Ph.D. is preferred
+ Professional designation in a Canadian province.
+ 10+ years in risk assessment consulting.
+ Track record of managing risk assessment from inception to completion.
**Preferred Qualifications**
+ Proficiency in practical, minimal credible scope development.
+ Strong project and personnel management capabilities.
+ Aptitude for strategic and business-focused thinking.
+ Strong technical writing skills for regulatory submittals and peer-reviewed reports.
+ Effective oral communication and stakeholder engagement capabilities
+ Valid Driver's License.
**Additional Information**
**Additional Information**
At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously. **_To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment._**
Offered rate of compensation will be based on individual education, qualifications, experience, and work location. The range for this position is $ to $ .
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines. Artificial intelligence will be used to support the screening, assessment, and selection of applicants for this role. Final hiring decisions are made by the hiring team.
**ReqID:** J
**Business Line:** Environment
**Business Group:** DCS
**Strategic Business Unit:** Canada
**Career Area:** Science
**Work Location Model:** Hybrid
**Compensation:** CAD - CAD - yearly
Is this job a match or a miss?
Apply Now
6
Job Description
At Stantec, we help deliver the critical minerals needed to power our world, from the cars we drive to the infrastructure powering our communities. And we don't just design the largest, deepest, and most technically challenging mines in the world-we do it sustainably. We're helping clients reduce energy usage, adopt clean energy sources, and implement digital solutions and automation.
Join our team of mining professionals and you'll be at the forefront of this evolving industry while building the mine of the future. You'll also build your own future, with exciting opportunities for development and advancement.
Your Opportunity
We are currently seeking a Study Manager to join our Mining team in Canada, based out of one of our offices in Vancouver, BC or Calgary, AB. The Study Manager is the principal liaison between Stantec and clients during the planning and execution of mining studies. The successful candidate will drive the identification, evaluation, selection, and/or optimization for a variety of mining projects as a key service offering for our diverse client base. You will have the opportunity to successfully steer complex studies through our various clients' stage gate processes, developing and applying robust study management techniques, while leading a multi-disciplinary team across multiple offices.
Your Key Responsibilities
- Understand the client's objectives and study definition guidelines.
- Drive the scope definition and execution planning for each study, working with a multi-disciplinary team to translate the client's objectives and study definition guidelines into an actionable, controllable scope of work and plan of execution.
- Implement study management processes and procedures, including risk and value management, option identification/evaluation/selection, and assurance activities as required.
- Deliver integrated studies on time and within budget, while ensuring alignment between engineering, estimating, scheduling and risk from Order-of-Magnitude / Preliminary Economic Assessments through to Definitive Feasibility Studies.
- Serve as a technical peer reviewer or Qualified Person in the execution of the technical components of the work. Answer questions and give daily guidance and communications to the project team, thus developing the team's technical competence.
- Assist the client with crafting the story of their studies, including engagement with other client stakeholders to present the progress and/or outcomes.
- Understand and implement various stage gate study standard processes.
- Lead the pursuit effort from identification through proposal development, successful proposal submission, and post-proposal support.
Your Capabilities and Credentials
- Proven mining study or project leadership experience with high emotional intelligence.
- Influential leader, capable of weighing contradicting priorities and securing buy-in on compromise.
- Risk management, commercial awareness, business analysis & reporting, and operational/business knowledge.
- Excellent communication and collaboration skills.
- An ability to effectively liaise with external and internal stakeholders from multiple cultures.
- Comfort in managing a complex environment with a virtual team based around the world.
- High degree of leadership, planning, teamwork, decision-making, judgment, and problem-solving skills.
- An aptitude for steering multi-disciplinary teams towards a common objective.
- Proven history of managing ambiguity and maintaining team progress during periods of significant change.
- Assessor of value and risk.
Education and Experience
- Bachelor's degree in Engineering, or a related field from an accredited university is preferred.
- Professional Engineering license (or the ability to obtain a license) is preferred.
- Minimum of 10 years of relevant study/project and/or program management experience.
- Direct study experience in the mining and or heavy industry sectors is advantageous.
- A Master of Business Administration degree, while not necessary, is viewed as an asset.
This description is not a comprehensive listing of activities, duties or responsibilities that may be required of the employee and other duties, responsibilities and activities may be assigned or may be changed at any time with or without notice.
Stantec is a place where the best and brightest come to build on each other's talents, do exciting work, and make an impact on the world around us. Join us and redefine your personal best. #FeelingEnergized
**Pay Range:**
- Locations in Lower Mainland - BC, GTA & Ottawa Ontario-$111,700.00 - $167,600.00 Annually
**Pay Transparency:** In compliance with pay transparency laws, pay ranges are provided for positions in locations where required. Please note, the final agreed upon compensation is based on individual education, qualifications, experience, and work location. At Stantec certain roles are bonus eligible. Actual compensation for part-time roles will be pro-rated based on the agreed number of working hours per week.
**Benefits Summary:** Regular full-time and part-time employees (working at least 20 hours per week) will have access to health, dental, and vision plans, a wellness program, health care spending account, wellness spending account, group registered retirement savings plan, employee stock purchase program, group tax-free savings account, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage, and paid time off.
Temporary/casual employees will have access to group registered retirement savings plan, employee stock purchase program, and group tax-free savings account.
The benefits information listed above may not apply to union positions because benefits for such positions are governed by applicable collective bargaining agreements.
**Primary Location:** Canada | BC | Vancouver
**Other Locations:** Canada | AB | Calgary
**Organization:** BC-1363 E&R-CA West
**Employee Status:** Regular
**Business Justification:** New Position
**Travel:** Yes
**Schedule:** Full time
**Job Posting:** 06/05/ :05:31
**Req ID:**
\#additional
Join our team of mining professionals and you'll be at the forefront of this evolving industry while building the mine of the future. You'll also build your own future, with exciting opportunities for development and advancement.
Your Opportunity
We are currently seeking a Study Manager to join our Mining team in Canada, based out of one of our offices in Vancouver, BC or Calgary, AB. The Study Manager is the principal liaison between Stantec and clients during the planning and execution of mining studies. The successful candidate will drive the identification, evaluation, selection, and/or optimization for a variety of mining projects as a key service offering for our diverse client base. You will have the opportunity to successfully steer complex studies through our various clients' stage gate processes, developing and applying robust study management techniques, while leading a multi-disciplinary team across multiple offices.
Your Key Responsibilities
- Understand the client's objectives and study definition guidelines.
- Drive the scope definition and execution planning for each study, working with a multi-disciplinary team to translate the client's objectives and study definition guidelines into an actionable, controllable scope of work and plan of execution.
- Implement study management processes and procedures, including risk and value management, option identification/evaluation/selection, and assurance activities as required.
- Deliver integrated studies on time and within budget, while ensuring alignment between engineering, estimating, scheduling and risk from Order-of-Magnitude / Preliminary Economic Assessments through to Definitive Feasibility Studies.
- Serve as a technical peer reviewer or Qualified Person in the execution of the technical components of the work. Answer questions and give daily guidance and communications to the project team, thus developing the team's technical competence.
- Assist the client with crafting the story of their studies, including engagement with other client stakeholders to present the progress and/or outcomes.
- Understand and implement various stage gate study standard processes.
- Lead the pursuit effort from identification through proposal development, successful proposal submission, and post-proposal support.
Your Capabilities and Credentials
- Proven mining study or project leadership experience with high emotional intelligence.
- Influential leader, capable of weighing contradicting priorities and securing buy-in on compromise.
- Risk management, commercial awareness, business analysis & reporting, and operational/business knowledge.
- Excellent communication and collaboration skills.
- An ability to effectively liaise with external and internal stakeholders from multiple cultures.
- Comfort in managing a complex environment with a virtual team based around the world.
- High degree of leadership, planning, teamwork, decision-making, judgment, and problem-solving skills.
- An aptitude for steering multi-disciplinary teams towards a common objective.
- Proven history of managing ambiguity and maintaining team progress during periods of significant change.
- Assessor of value and risk.
Education and Experience
- Bachelor's degree in Engineering, or a related field from an accredited university is preferred.
- Professional Engineering license (or the ability to obtain a license) is preferred.
- Minimum of 10 years of relevant study/project and/or program management experience.
- Direct study experience in the mining and or heavy industry sectors is advantageous.
- A Master of Business Administration degree, while not necessary, is viewed as an asset.
This description is not a comprehensive listing of activities, duties or responsibilities that may be required of the employee and other duties, responsibilities and activities may be assigned or may be changed at any time with or without notice.
Stantec is a place where the best and brightest come to build on each other's talents, do exciting work, and make an impact on the world around us. Join us and redefine your personal best. #FeelingEnergized
**Pay Range:**
- Locations in Lower Mainland - BC, GTA & Ottawa Ontario-$111,700.00 - $167,600.00 Annually
**Pay Transparency:** In compliance with pay transparency laws, pay ranges are provided for positions in locations where required. Please note, the final agreed upon compensation is based on individual education, qualifications, experience, and work location. At Stantec certain roles are bonus eligible. Actual compensation for part-time roles will be pro-rated based on the agreed number of working hours per week.
**Benefits Summary:** Regular full-time and part-time employees (working at least 20 hours per week) will have access to health, dental, and vision plans, a wellness program, health care spending account, wellness spending account, group registered retirement savings plan, employee stock purchase program, group tax-free savings account, life and accidental death & dismemberment (AD&D) insurance, short-term/long-term disability plans, emergency travel benefits, tuition reimbursement, professional membership fee coverage, and paid time off.
Temporary/casual employees will have access to group registered retirement savings plan, employee stock purchase program, and group tax-free savings account.
The benefits information listed above may not apply to union positions because benefits for such positions are governed by applicable collective bargaining agreements.
**Primary Location:** Canada | BC | Vancouver
**Other Locations:** Canada | AB | Calgary
**Organization:** BC-1363 E&R-CA West
**Employee Status:** Regular
**Business Justification:** New Position
**Travel:** Yes
**Schedule:** Full time
**Job Posting:** 06/05/ :05:31
**Req ID:**
\#additional
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Apply Now
7
Job Description
**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**Western Canada Aquatic Discipline Lead**
AECOM Burnaby is seeking an experienced Aquatic Discipline Lead for Western Canada to support our EPP Ecology and Permitting team. In this role, you will be the go-to expert for aquatic ecology in in Western Canada, providing leadership, technical oversight, and strategic direction. You will guide best practices, ensure high quality project delivering, and collaborate across disciplines, business lines, and with our clients.
As the Aquatic Discipline Lead for Western Canada, you will work closely with other Aquatic Discipline Leads and the Ecological Management Technical Lead for Canada Region to align technical standards and advance practice-wide excellence.
This role is based in Burnaby, BC and requires a minimum of two days per week in-office presence.
**Key Responsibilities:**
**_Advance Technical Excellence and Quality_**
+ Develop, implement, and improve technical standards, protocols, and best practices for aquatic work in BC and across Canada
+ Provide technical expertise on EPP Ecology and Permitting projects, including reviewing work scopes and client deliverables
+ Ensure technical excellence and consistency through project oversight and quality reviews
+ Promote innovation and continuous improvement by applying lessons learned and emerging best practices
+ Demonstrate creativity and foresight in anticipating and solving both routine and unusual project delivery and technical problems
+ Serving as a technical resource to staff, other practices, business lines, and our clients
+ Maintain regular communication with regulators, clients, and other AECOM technical staff/project managers to support project delivery
**_Staff Stewardship and Mentoring_**
+ Provide mentorship and guidance to staff to build technical capabilities and support career development
+ Set an example for the best practices of safety, quality and technical excellence
+ Identify technical skill gaps and support targeted training, development, and succession planning
**_Growth, Strategy, and Client Engagement_**
+ Build and maintain strong client relationships, acting as a senior technical representative for AECOM
+ Support business development by identifying opportunities, leading or contributing to pursuits, and helping position the right technical experts
+ Develop strategic proposals, scopes, and budgets to grow the Environment business line backlog
+ Work with the technical leadership team to identify market sectors and opportunities that align with our technical skills and experience
+ Assess team capabilities to inform hiring and training strategies
**Qualifications**
**Minimum Requirements:**
+ Bachelor's Degree in a relevant discipline (Aquatics, Water Quality, Marine Biology, Environment Related Technical discipline, etc.)
+ 6+ years consulting experience leading environmental projects
+ Experience with regulatory applications and reporting requirements in BC
+ Registered Professional Biologist (RPBio) with BC's College of Applied Biologists (or clear evidence of eligibility to meet registration requirements)
+ Valid Driver's License
**Preferred Qualifications:**
+ Master's Degree in a relevant discipline (Aquatics, Water Quality, Marine Biology, Environment Related Technical discipline, etc.)
+ 15+ years consulting experience leading projects in BC or more widely in Western Canada
+ Strong client management skills
+ Proven business development experience, including pursuing and winning environmental work in Canada
+ Demonstrated ability to collaborate effectively in multidisciplinary teams
+ Experience with regulatory applications and reporting requirements in BC, AB and Northern Canada
+ Experience with Federal Impact Assessments
+ Excellent verbal and written communication skills
+ Strong interpersonal and organizational skills
**Additional Information**
+ **Sponsorship for obtaining a Canadian work permit is not available for this position**
At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously. **_To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment._**
Offered rate of compensation will be based on individual education, qualifications, experience, and work location. The range for this position is $ to $ .
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines. Artificial intelligence will be used to support the screening, assessment, and selection of applicants for this role. Final hiring decisions are made by the hiring team.
**ReqID:** J
**Business Line:** Environment
**Business Group:** DCS
**Strategic Business Unit:** Canada
**Career Area:** Science
**Work Location Model:** Hybrid
**Compensation:** CAD - CAD - yearly
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**Western Canada Aquatic Discipline Lead**
AECOM Burnaby is seeking an experienced Aquatic Discipline Lead for Western Canada to support our EPP Ecology and Permitting team. In this role, you will be the go-to expert for aquatic ecology in in Western Canada, providing leadership, technical oversight, and strategic direction. You will guide best practices, ensure high quality project delivering, and collaborate across disciplines, business lines, and with our clients.
As the Aquatic Discipline Lead for Western Canada, you will work closely with other Aquatic Discipline Leads and the Ecological Management Technical Lead for Canada Region to align technical standards and advance practice-wide excellence.
This role is based in Burnaby, BC and requires a minimum of two days per week in-office presence.
**Key Responsibilities:**
**_Advance Technical Excellence and Quality_**
+ Develop, implement, and improve technical standards, protocols, and best practices for aquatic work in BC and across Canada
+ Provide technical expertise on EPP Ecology and Permitting projects, including reviewing work scopes and client deliverables
+ Ensure technical excellence and consistency through project oversight and quality reviews
+ Promote innovation and continuous improvement by applying lessons learned and emerging best practices
+ Demonstrate creativity and foresight in anticipating and solving both routine and unusual project delivery and technical problems
+ Serving as a technical resource to staff, other practices, business lines, and our clients
+ Maintain regular communication with regulators, clients, and other AECOM technical staff/project managers to support project delivery
**_Staff Stewardship and Mentoring_**
+ Provide mentorship and guidance to staff to build technical capabilities and support career development
+ Set an example for the best practices of safety, quality and technical excellence
+ Identify technical skill gaps and support targeted training, development, and succession planning
**_Growth, Strategy, and Client Engagement_**
+ Build and maintain strong client relationships, acting as a senior technical representative for AECOM
+ Support business development by identifying opportunities, leading or contributing to pursuits, and helping position the right technical experts
+ Develop strategic proposals, scopes, and budgets to grow the Environment business line backlog
+ Work with the technical leadership team to identify market sectors and opportunities that align with our technical skills and experience
+ Assess team capabilities to inform hiring and training strategies
**Qualifications**
**Minimum Requirements:**
+ Bachelor's Degree in a relevant discipline (Aquatics, Water Quality, Marine Biology, Environment Related Technical discipline, etc.)
+ 6+ years consulting experience leading environmental projects
+ Experience with regulatory applications and reporting requirements in BC
+ Registered Professional Biologist (RPBio) with BC's College of Applied Biologists (or clear evidence of eligibility to meet registration requirements)
+ Valid Driver's License
**Preferred Qualifications:**
+ Master's Degree in a relevant discipline (Aquatics, Water Quality, Marine Biology, Environment Related Technical discipline, etc.)
+ 15+ years consulting experience leading projects in BC or more widely in Western Canada
+ Strong client management skills
+ Proven business development experience, including pursuing and winning environmental work in Canada
+ Demonstrated ability to collaborate effectively in multidisciplinary teams
+ Experience with regulatory applications and reporting requirements in BC, AB and Northern Canada
+ Experience with Federal Impact Assessments
+ Excellent verbal and written communication skills
+ Strong interpersonal and organizational skills
**Additional Information**
+ **Sponsorship for obtaining a Canadian work permit is not available for this position**
At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously. **_To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment._**
Offered rate of compensation will be based on individual education, qualifications, experience, and work location. The range for this position is $ to $ .
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines. Artificial intelligence will be used to support the screening, assessment, and selection of applicants for this role. Final hiring decisions are made by the hiring team.
**ReqID:** J
**Business Line:** Environment
**Business Group:** DCS
**Strategic Business Unit:** Canada
**Career Area:** Science
**Work Location Model:** Hybrid
**Compensation:** CAD - CAD - yearly
Is this job a match or a miss?
Apply Now
8
Job Description
**Requisition ID:**
**Job Level:** Senior Level
**Home District/Group:** Kiewit Nuclear Solutions
**Department:** Design Engineering
**Market:** Nuclear
**Employment Type:** Full Time
**Position Overview**
Join our premier in-house engineering team, a diverse group of professionals delivering high-impact projects across the nuclear energy sector. As the Mechanical Engineering Discipline Lead, you will play a pivotal role in leading complex engineering efforts for nuclear facilities including Nuclear New Build, with a strong emphasis on safety, regulatory compliance, and innovation. This role is ideal for a seasoned mechanical engineer with a proven track record in nuclear projects and direct experience working with Nuclear clients.
**Candidates must have at least 5 years of experience in nuclear projects.**
**District Overview**
Kiewit Nuclear Solutions is a full-service engineering, project management and construction provider operating across North America. Our experience spans all aspects of the nuclear market from carbon-free, small modular reactors to Department of Energy science, environmental and nuclear security mission capabilities. With these broad capabilities, we operate in the power utility, renewable energy, industrial and infrastructure markets.
**Location**
This position is based in Oakville, ON, with flexible work arrangements available. Occasional travel to project sites and client offices will be required.
**Responsibilities**
- Lead the mechanical engineering discipline on nuclear projects, ensuring technical excellence, regulatory compliance, and alignment with client expectations.
- Serve as the primary point of contact for mechanical engineering matters with the client and other stakeholders.
- Oversee the preparation and review of engineering deliverables including P&IDs, BOM's, equipment specifications, piping layouts, stress analyses, and HVAC designs.
- Ensure all designs meet Canadian nuclear regulatory standards (e.g., CSA N285, N286, N299 series, CNSC requirements).
- Lead and mentor a team of mechanical engineers and designers, fostering a culture of technical rigor, compliance, and continuous improvement.
- Coordinate with multi-disciplinary teams and client stakeholders to ensure integrated and optimized project delivery.
- Encourage and challenge the engineering team to drive "fit for purpose" solutions while being fully compliant with nuclear codes and standards.
- Review and approve vendor documentation, ensuring alignment with project specifications and nuclear safety requirements.
- Conduct and oversee mechanical system analyses including seismic thermal-hydraulic calculations, pressure drop analysis, and equipment sizing.
- Provide engineering support during construction (RFI responses, field changes, NCR resolution).
- Support commissioning planning, procedures, and system turnover.
- Support preparation of:
o Licensing submissions (e.g., License to Prepare Site, Construct, Operate)
o Design justification reports and compliance matrices
- Drive innovation and cost-effective solutions while maintaining the highest standards of safety and quality.
- Support proposal development, project planning, and client presentations.
- Identify and manage scope changes, risks, and opportunities throughout the project lifecycle.
\#LI-KM2
**Qualifications**
- A Bachelor's degree in Mechanical Engineering is required.
- A Master's degree in Mechanical Engineering preferred.
- Licensed Professional Engineer (P.Eng.) in Ontario is required.
- A minimum of 15 years of experience in mechanical engineering, with at least 5 years in nuclear projects is required.
- Direct experience with a Nuclear Client-either as an employee, contractor, or consultant.
- Active security clearance.
- Experience with delivering complex projects.
- Deep understanding of Canadian nuclear codes and standards (e.g., CSA N285, N286, N299).
- Demonstrated leadership in managing engineering teams and delivering complex, multi-disciplinary projects.
- Effective communication and stakeholder engagement skills, including experience in client-facing roles.
- Proficiency in mechanical analysis tools and software (e.g., ANSYS, Caesar II, AutoPIPE and others).
- Knowledge of ASME, ANSI, API, and Canadian Building Code standards.
- Proven ability to manage competing priorities and deliver high-quality results under tight deadlines.
Other Requirements:
+ Regular, reliable attendance
+ Work productively and meet deadlines timely
+ Communicate and interact effectively and professionally with supervisors, employees, and others individually or in a team environment
+ Perform work safely and effectively. Understand and follow oral and written instructions, including warning signs, equipment use, and other policies.
+ Work during normal operating hours to organize and complete work within given deadlines. Work overtime and weekends as required.
+ May work at various different locations and conditions may vary
+ Openings are to fill both existing vacancies and newly created positions
Base Compensation: $152,000/yr - $159,000/yr
(Actual compensation is subject to variation due to such factors as education, experience, skillset, and/or location)
We offer our fulltime staff employees a comprehensive benefits package that's among the best in our industry, including top-tier medical, dental and vision plans covering eligible employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and generous paid time off.
We believe in equal opportunity in employment practices without discrimination and comply with all laws regarding human rights in the provinces where we operate.
Company: Kiewit
**Job Level:** Senior Level
**Home District/Group:** Kiewit Nuclear Solutions
**Department:** Design Engineering
**Market:** Nuclear
**Employment Type:** Full Time
**Position Overview**
Join our premier in-house engineering team, a diverse group of professionals delivering high-impact projects across the nuclear energy sector. As the Mechanical Engineering Discipline Lead, you will play a pivotal role in leading complex engineering efforts for nuclear facilities including Nuclear New Build, with a strong emphasis on safety, regulatory compliance, and innovation. This role is ideal for a seasoned mechanical engineer with a proven track record in nuclear projects and direct experience working with Nuclear clients.
**Candidates must have at least 5 years of experience in nuclear projects.**
**District Overview**
Kiewit Nuclear Solutions is a full-service engineering, project management and construction provider operating across North America. Our experience spans all aspects of the nuclear market from carbon-free, small modular reactors to Department of Energy science, environmental and nuclear security mission capabilities. With these broad capabilities, we operate in the power utility, renewable energy, industrial and infrastructure markets.
**Location**
This position is based in Oakville, ON, with flexible work arrangements available. Occasional travel to project sites and client offices will be required.
**Responsibilities**
- Lead the mechanical engineering discipline on nuclear projects, ensuring technical excellence, regulatory compliance, and alignment with client expectations.
- Serve as the primary point of contact for mechanical engineering matters with the client and other stakeholders.
- Oversee the preparation and review of engineering deliverables including P&IDs, BOM's, equipment specifications, piping layouts, stress analyses, and HVAC designs.
- Ensure all designs meet Canadian nuclear regulatory standards (e.g., CSA N285, N286, N299 series, CNSC requirements).
- Lead and mentor a team of mechanical engineers and designers, fostering a culture of technical rigor, compliance, and continuous improvement.
- Coordinate with multi-disciplinary teams and client stakeholders to ensure integrated and optimized project delivery.
- Encourage and challenge the engineering team to drive "fit for purpose" solutions while being fully compliant with nuclear codes and standards.
- Review and approve vendor documentation, ensuring alignment with project specifications and nuclear safety requirements.
- Conduct and oversee mechanical system analyses including seismic thermal-hydraulic calculations, pressure drop analysis, and equipment sizing.
- Provide engineering support during construction (RFI responses, field changes, NCR resolution).
- Support commissioning planning, procedures, and system turnover.
- Support preparation of:
o Licensing submissions (e.g., License to Prepare Site, Construct, Operate)
o Design justification reports and compliance matrices
- Drive innovation and cost-effective solutions while maintaining the highest standards of safety and quality.
- Support proposal development, project planning, and client presentations.
- Identify and manage scope changes, risks, and opportunities throughout the project lifecycle.
\#LI-KM2
**Qualifications**
- A Bachelor's degree in Mechanical Engineering is required.
- A Master's degree in Mechanical Engineering preferred.
- Licensed Professional Engineer (P.Eng.) in Ontario is required.
- A minimum of 15 years of experience in mechanical engineering, with at least 5 years in nuclear projects is required.
- Direct experience with a Nuclear Client-either as an employee, contractor, or consultant.
- Active security clearance.
- Experience with delivering complex projects.
- Deep understanding of Canadian nuclear codes and standards (e.g., CSA N285, N286, N299).
- Demonstrated leadership in managing engineering teams and delivering complex, multi-disciplinary projects.
- Effective communication and stakeholder engagement skills, including experience in client-facing roles.
- Proficiency in mechanical analysis tools and software (e.g., ANSYS, Caesar II, AutoPIPE and others).
- Knowledge of ASME, ANSI, API, and Canadian Building Code standards.
- Proven ability to manage competing priorities and deliver high-quality results under tight deadlines.
Other Requirements:
+ Regular, reliable attendance
+ Work productively and meet deadlines timely
+ Communicate and interact effectively and professionally with supervisors, employees, and others individually or in a team environment
+ Perform work safely and effectively. Understand and follow oral and written instructions, including warning signs, equipment use, and other policies.
+ Work during normal operating hours to organize and complete work within given deadlines. Work overtime and weekends as required.
+ May work at various different locations and conditions may vary
+ Openings are to fill both existing vacancies and newly created positions
Base Compensation: $152,000/yr - $159,000/yr
(Actual compensation is subject to variation due to such factors as education, experience, skillset, and/or location)
We offer our fulltime staff employees a comprehensive benefits package that's among the best in our industry, including top-tier medical, dental and vision plans covering eligible employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and generous paid time off.
We believe in equal opportunity in employment practices without discrimination and comply with all laws regarding human rights in the provinces where we operate.
Company: Kiewit
Is this job a match or a miss?
Apply Now
9