163 Oncology jobs in Canada

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 Clinical Research Associate.
ICON plc est une organisation de premier plan spécialisée en intelligence en santé et en recherche clinique. Nous sommes fiers de favoriser un environnement inclusif qui stimule l'innovation et l'excellence. Nous vous invitons à vous joindre à nous dans notre mission visant à façonner l'avenir du développement clinique en tant qu'Associé(e) de recherche clinique.
**What you will be doing:**
+ Oversee multiple oncology trials, ensuring high-quality execution
+ Provide leadership and mentorship to junior flex team members
+ Act as Lead SM, training and guiding other Site Managers on study protocols
+ Develop essential study start-up documents, including SIV agendas
+ Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
+ Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
+ Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
+ Support country budget development and contract negotiations in collaboration with CCS colleagues
+ Assist with ASV activities and ensure alignment with study objectives
+ Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)
**Ce que vous ferez :**
+ Superviser plusieurs essais en oncologie, en veillant à leur exécution de haute qualité
+ Fournir du leadership et du mentorat aux membres juniors de l'équipe flexible
+ Agir en tant que Gestionnaire de Site principal (Lead SM), en formant et guidant les autres Gestionnaires de Site sur les protocoles d'étude
+ Développer des documents essentiels pour le démarrage des études, y compris les ordres du jour des visites de mise en place des sites (SIV)
+ Représenter les Gestionnaires de Site et les Gestionnaires d'Essai Principaux (LTMs) lors de réunions clés
+ S'assurer que la perspective des Gestionnaires de Site est bien reflétée dans les documents d'étude, comme les Lignes directrices de Surveillance
+ Réviser les rapports (SQV, SMV, SCV) pour les sites attribués à d'autres Gestionnaires de Site dans le même essai
+ Soutenir le développement des budgets pays et les négociations contractuelles en collaboration avec les collègues du CCS
+ Assister aux activités ASV et veiller à l'alignement avec les objectifs de l'étude
+ Maintenir la conformité aux indicateurs de performance (Metrics/KPIs) conformément au Plan de Surveillance de la Qualité (QOP)
**You Are:**
+ Remote position located in Montreal
+ Bilingual - Proficient in both written and spoken French and English.
+ Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
+ At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
+ Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
+ Knowledge of risk-based/analytical monitoring approaches is an asset
+ Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
+ Ability to actively drive patient recruitment strategies at assigned sites
+ Strong collaboration with investigators and site staff to meet study timelines
+ Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
+ Ability to work independently while being a strong collaborator
+ In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
+ Up to 50% regional travel required
**Vous êtes :**
+ Poste en télétravail basé à Montréal
+ Bilingue - Maîtrise du français et de l'anglais, à l'écrit comme à l'oral
+ Titulaire d'un B.Sc., d'un diplôme d'infirmier(ère) autorisé(e) (R.N.), ou d'un diplôme équivalent, de préférence en sciences biologiques
+ Minimum de 2 ans d'expérience en surveillance d'essais cliniques dans l'industrie pharmaceutique
+ Expérience dans plusieurs aires thérapeutiques, un atout - particulièrement en oncologie (hématologie, cancer de la prostate, cancer du poumon, développement précoce - phase 1)
+ Connaissance des approches de surveillance analytique/basée sur les risques, un atout
+ Maîtrise des systèmes d'essais cliniques : CTMS, EDC, TMF, IWRS et outils de déclaration de sécurité
+ Capacité à piloter activement les stratégies de recrutement de patients sur les sites assignés
+ Forte collaboration avec les investigateurs et le personnel des sites pour respecter les échéanciers de l'étude
+ Excellentes compétences en communication et en influence pour gérer efficacement les sites d'étude, à distance et en présentiel
+ Capacité à travailler de manière autonome tout en favorisant une collaboration efficace
+ Connaissance approfondie des Bonnes Pratiques Cliniques (BPC), des lignes directrices ICH et des exigences réglementaires locales
+ Disponibilité pour voyager jusqu'à 50 % dans la région
**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 maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: 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, colour, 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 through the form below.
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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

Responsibilities:

• Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
• For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
• Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
• Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;
• Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders;
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times;
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency);
• You will be responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans;
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines;
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development;
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including 2 years' project management experience - experience on a global level is desirable
• Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
• Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.