Development Scientist, Oncology Clinical Development
Markham, Ontario
Astellas Pharma
Posted today
Job Viewed
Job Description
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Ontario, Canada. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Development Physician. The role is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives.
**Essential Job Responsibilities:**
+ Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting).
+ Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making.
+ Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings.
+ Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports)
+ Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans.
+ Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
+ Together with the clinical lead and Product Responsible Person, prepares analysis for DMC/DSMB/DEC forums or regulatory submissions.
+ Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings.
+ Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
+ Shows relevant expertise related to Study Data Review and Analysis:
+ Provides clinical input into statistical planning, data analysis, and interpretation.
+ Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease- or technology-related scientific publications.
+ Works closely with operations groups for site and vendor feasibility, trial set up, and data monitoring.
+ Leads the execution of contracts, particularly for investigator meetings and advisories.
+ Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
+ Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
+ May represent clinical development and assist with clinical assessment of new assets for potential in-licensing and acquisition.
+ Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
+ Performs other duties as assigned or special projects as required.
+ This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels.
+ This position reports to the IO Development Medical Lead/Head of disease area strategy.
**Qualifications Required:**
+ Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-8 years clinical, scientific/research, pathology, or industry experience; combination of academia and industry is acceptable.
+ Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study start-up & execution to regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S.
+ Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
+ Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g., electronic data capture systems (RAVE, InForm, etc.)) and proficient in data analysis software (e.g., Excel, SigmaPlot, SPSS, R, etc.).
+ Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
+ Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
+ Knowledge of global pharmacovigilance standards and guidance documents. Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
+ Excellent strategic planning, organizational, and verbal and written communication skills.
+ Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions.
+ Highest level of scientific integrity and impeccable work ethics.
+ Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
+ Able to travel ~25%, with international travel as required.
**Salary Range**
$180K - $230K (NOTE: Final salary could be more or less, based on experience)
**Preferred:**
+ MD., PharmD, or other relevant master's degree.
+ Knowledge and proficiency related to Immuno-Oncology clinical research
**Working Environment:**
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**#LI-SS**
Category Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Ontario, Canada. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Development Physician. The role is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives.
**Essential Job Responsibilities:**
+ Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting).
+ Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making.
+ Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings.
+ Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports)
+ Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans.
+ Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
+ Together with the clinical lead and Product Responsible Person, prepares analysis for DMC/DSMB/DEC forums or regulatory submissions.
+ Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings.
+ Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
+ Shows relevant expertise related to Study Data Review and Analysis:
+ Provides clinical input into statistical planning, data analysis, and interpretation.
+ Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease- or technology-related scientific publications.
+ Works closely with operations groups for site and vendor feasibility, trial set up, and data monitoring.
+ Leads the execution of contracts, particularly for investigator meetings and advisories.
+ Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
+ Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
+ May represent clinical development and assist with clinical assessment of new assets for potential in-licensing and acquisition.
+ Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
+ Performs other duties as assigned or special projects as required.
+ This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels.
+ This position reports to the IO Development Medical Lead/Head of disease area strategy.
**Qualifications Required:**
+ Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-8 years clinical, scientific/research, pathology, or industry experience; combination of academia and industry is acceptable.
+ Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study start-up & execution to regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S.
+ Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
+ Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g., electronic data capture systems (RAVE, InForm, etc.)) and proficient in data analysis software (e.g., Excel, SigmaPlot, SPSS, R, etc.).
+ Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
+ Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
+ Knowledge of global pharmacovigilance standards and guidance documents. Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
+ Excellent strategic planning, organizational, and verbal and written communication skills.
+ Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions.
+ Highest level of scientific integrity and impeccable work ethics.
+ Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
+ Able to travel ~25%, with international travel as required.
**Salary Range**
$180K - $230K (NOTE: Final salary could be more or less, based on experience)
**Preferred:**
+ MD., PharmD, or other relevant master's degree.
+ Knowledge and proficiency related to Immuno-Oncology clinical research
**Working Environment:**
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**#LI-SS**
Category Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.
0
Sr. Clinical Research Associate - Oncology - FSP
Ontario, Ontario
Parexel
Posted 7 days ago
Job Viewed
Job Description
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
#LI-LO1
#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.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
#LI-LO1
#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.
This advertiser has chosen not to accept applicants from your region.
1
Nurse Practitioner - Oncology
Brampton, Ontario
William Osler Health System
Posted today
Job Viewed
Job Description
Job Description
Additional Information
Job Description
Company Description
One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.
A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of world-class health care inspired by our people and communities.
At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today!
Job Description- In consultation/collaboration with the Oncology Program Medical Director and patient care team, the Nurse Practitioner engages in direct clinical practice by:
- Assessing patient needs
- Diagnosing and prescribing within scope of practice and approved medical directive protocols
- Monitoring patient progress, documenting and re-evaluating the patient’s plan of care
- Identifies clinical practice issues and demonstrates a high level of autonomy and expert skill to formulate clinical decisions and appropriately manage acute/chronic illness, promotes wellness and the educational needs for the acute oncology patient populations in the Oncology Inpatient Unit and Urgent Clinic
- Engages in in-service activities and clinical teaching for the oncology patient care team where necessary
- Leads the development and implementation of corporate wide protocols related to the oncology patient
- Engages in evidence based practice through research
- Acts as consultant for the organization internally and externally to advise on systems related to the oncology population
- Master’s degree in Nursing
- Acute Care Nurse Practitioner Certificate required
- Current registration with the College of Nurses
- Minimum 2 years recent nursing experience in Oncology care
- Minimum 2 years ACNP experience in the Oncology field
- Excellent decision making, critical thinking and problem solving skills
- Excellent negotiation and conflict resolution skills
- Ability to lead and motivate teams
- Effective verbal and written communication skills
- Knowledge of computerized data management and statistical analysis
- Excellent attendance, punctuality and work record
Additional Information
Hours: Hours: Currently Days, 8 hours including weekends and statutory holidays (subject to change in accordance with operational requirements)
Salary:
Minimum: $62.16 per hour
Maximum: $77.42 per hour
Internal application deadline: (August 26, 2025)
#LI-SC1
Osler values inclusivity and diversity in the workplace. We welcome and encourage applicants from diverse backgrounds. We are committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act. If you require an accommodation at any stage of the recruitment process, please notify Human Resources at
While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.
This advertiser has chosen not to accept applicants from your region.
2
Clinical Research Associate - Oncology/Cross TA - Toronto (Field-Based)
Toronto, Ontario
ICON Clinical Research
Posted today
Job Viewed
Job Description
As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Greater Toronto Area
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans la région du Grand Toronto
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Greater Toronto Area
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans la région du Grand Toronto
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
This advertiser has chosen not to accept applicants from your region.
3
Clinical Research Associate - Oncology/Cross TA - Toronto (Field-Based)
Toronto, Ontario
ICON Clinical Research
Posted today
Job Viewed
Job Description
As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Greater Toronto Area
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans la région du Grand Toronto
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Greater Toronto Area
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans la région du Grand Toronto
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
This advertiser has chosen not to accept applicants from your region.
4
Oncology Omnichannel Analytics Partner
Markham, Ontario
Astellas Pharma
Posted 28 days ago
Job Viewed
Job Description
**Oncology Omnichannel Analytics Partner**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Canada and will not require on-site work. However, there may be occasional travel to Northbrook office required.
**Purpose:**
The Omnichannel Analytics (OCA) Partner plays a critical role in providing valuable strategic and tactical business insight and recommendations to Marketing, Agencies and Omnichannel Strategy & Operations (OSO) teams to support achievement of brand promotional and campaign objectives. This role will be responsible for leveraging data to drive insights, optimize customer experiences, and contribute to the overall success of our omnichannel initiatives. This position will play a key role in various Omnichannel analytics projects, which will analyze and measure the promotional effectiveness of omnichannel activities using advanced machine learning models.
This position will work collaboratively with partners such as global/ regional commercial brand teams/marketing, global/regional Commercial Insights teams, Omnichannel Strategy & Operations, Data Governance, and Information Systems team and will contribute to data/metrics harmonization and insights sharing.
**Essential Job Responsibilities:**
+ Collaborate with key brand stakeholders and cross-functional teams to understand business objectives and campaign measurability and develop analytic plans to measure performance and inform data-driven strategies that enhance the omnichannel experience.
+ Provide consulting to the key stakeholders in the campaign design/requirements gathering phase to ensure objectives are clearly defined and can be measured, content assets are properly tagged, and the campaign data is properly sourced to ensure integrity of the measurement.
+ Take ownership of ensuring all Omnichannel data, including personal and non-personal tactics, are integrated into the Astellas' internal data warehouse, thoroughly quality-checked against media plans and spend, and validated for accuracy in collaboration with agency partners. Monitor data trends and anomalies to support validation efforts and proactively identify potential discrepancies.
+ Own the management of all non-personal target lists, including conducting analyses to evaluate and determine the inclusion of HCPs based on predefined criteria and strategic objectives. Ensure target lists are optimized and aligned with campaign goals.
+ Provide actionable insights through on-going reporting and ad hoc analyses of all omnichannel engagements and digital tactics, including personal and non-personal promotions.
+ Develop and implement machine learning algorithms to drive personalized recommendations and targeted marketing campaigns across channels based on individual preferences and behaviors.
+ Conduct in-depth analysis of various data sources (promotional and non-promotional data) and develop predictive models to forecast HCP preferences, behavior, and overall omnichannel engagement.
+ Work with various cross-functional teams (Marketing, Media Agencies, IS and Data Engineering) to integrate and consolidate all promotional data from various sources, ensuring a unified view of customer interactions and transactions.
+ Work closely with Media agency partners on performance reporting construct and media execution governance.
+ Troubleshoot data quality issues and implement solutions to maintain accurate and reliable data.
+ Develop and implement key performance indicators (KPIs) to measure the effectiveness of omnichannel initiatives.
+ Develop and implement analytics plans to support campaign, brand and portfolio level optimization.
+ Stay abreast of industry trends, emerging technologies, and best practices in data science and omnichannel strategies.
+ Manage third party providers on an as-needed basis and ensure deliverables fully meet contractual obligations and are of highest caliber.
+ Embed an Ethics and Compliance culture and Integrity in Action by proactively addressing non-compliance.
**Quantitative Dimensions:**
+ Quality of strategic and operational support for assigned products including quality of the collaboration with key partners and copromote partners were applicable.
+ Accuracy, timeliness, effectiveness, and ease of use of production and ad hoc performance reporting, dashboards, and advanced analytics.
+ Ability to meet/exceed established key milestones related to assigned major projects.
+ Quality/timeliness of insight generation and development of actionable recommendations based on feedback from key customers and cross-functional colleagues.
+ Management of projects within approved operating budget, with a focus on performing tasks internally whenever possible, rather than outsourcing or delegating to other internal resources.
**Organizational Context:**
+ Reports to the Director, Brand Analytics.
+ This position requires extensive collaboration across the global Commercial Insights GCA team. This role will also have broad global exposure as they partner with cross-functional colleagues (Marketing, Sales, Finance, Data Strategy/Data Engineering, Sales Operations (where applicable) and IS) within global functions and priority Commercial Divisions/markets. Additional collaboration is required with co-promotion partners (if applicable).
**Qualifications Required:**
+ Master's in Data Science, Statistics, Computer Science, or a related field.
+ Minimum 6 years of analytics/data science experience with a focus on omnichannel analytics and demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Strong proficiency in coding language (e.g. SQL, R and/or Python).
+ Proficiency in machine learning techniques, statistical analysis, and data visualization, including classification models, promotion response modeling, predictive modeling, etc.
+ Strong knowledge of omnichannel concepts and data sources, e.g., impressions/click data, web data, etc.
+ Strong understanding of digital marketing media and promotional tactics within Pharma space.
+ Experience working with Google Analytics or Adobe Analytics.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
**Preferred:**
+ Pharmaceutical industry experience.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence).
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense.
+ Experience working with global partners.
+ Knowledge of the global healthcare landscape including different access models.
+ Knowledge of other healthcare data sources such as patient-level data.
_Flexible grade level based on candidate background and skillset_
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**#LI-LN2**
Category Strategic Insights & Analytics
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Canada and will not require on-site work. However, there may be occasional travel to Northbrook office required.
**Purpose:**
The Omnichannel Analytics (OCA) Partner plays a critical role in providing valuable strategic and tactical business insight and recommendations to Marketing, Agencies and Omnichannel Strategy & Operations (OSO) teams to support achievement of brand promotional and campaign objectives. This role will be responsible for leveraging data to drive insights, optimize customer experiences, and contribute to the overall success of our omnichannel initiatives. This position will play a key role in various Omnichannel analytics projects, which will analyze and measure the promotional effectiveness of omnichannel activities using advanced machine learning models.
This position will work collaboratively with partners such as global/ regional commercial brand teams/marketing, global/regional Commercial Insights teams, Omnichannel Strategy & Operations, Data Governance, and Information Systems team and will contribute to data/metrics harmonization and insights sharing.
**Essential Job Responsibilities:**
+ Collaborate with key brand stakeholders and cross-functional teams to understand business objectives and campaign measurability and develop analytic plans to measure performance and inform data-driven strategies that enhance the omnichannel experience.
+ Provide consulting to the key stakeholders in the campaign design/requirements gathering phase to ensure objectives are clearly defined and can be measured, content assets are properly tagged, and the campaign data is properly sourced to ensure integrity of the measurement.
+ Take ownership of ensuring all Omnichannel data, including personal and non-personal tactics, are integrated into the Astellas' internal data warehouse, thoroughly quality-checked against media plans and spend, and validated for accuracy in collaboration with agency partners. Monitor data trends and anomalies to support validation efforts and proactively identify potential discrepancies.
+ Own the management of all non-personal target lists, including conducting analyses to evaluate and determine the inclusion of HCPs based on predefined criteria and strategic objectives. Ensure target lists are optimized and aligned with campaign goals.
+ Provide actionable insights through on-going reporting and ad hoc analyses of all omnichannel engagements and digital tactics, including personal and non-personal promotions.
+ Develop and implement machine learning algorithms to drive personalized recommendations and targeted marketing campaigns across channels based on individual preferences and behaviors.
+ Conduct in-depth analysis of various data sources (promotional and non-promotional data) and develop predictive models to forecast HCP preferences, behavior, and overall omnichannel engagement.
+ Work with various cross-functional teams (Marketing, Media Agencies, IS and Data Engineering) to integrate and consolidate all promotional data from various sources, ensuring a unified view of customer interactions and transactions.
+ Work closely with Media agency partners on performance reporting construct and media execution governance.
+ Troubleshoot data quality issues and implement solutions to maintain accurate and reliable data.
+ Develop and implement key performance indicators (KPIs) to measure the effectiveness of omnichannel initiatives.
+ Develop and implement analytics plans to support campaign, brand and portfolio level optimization.
+ Stay abreast of industry trends, emerging technologies, and best practices in data science and omnichannel strategies.
+ Manage third party providers on an as-needed basis and ensure deliverables fully meet contractual obligations and are of highest caliber.
+ Embed an Ethics and Compliance culture and Integrity in Action by proactively addressing non-compliance.
**Quantitative Dimensions:**
+ Quality of strategic and operational support for assigned products including quality of the collaboration with key partners and copromote partners were applicable.
+ Accuracy, timeliness, effectiveness, and ease of use of production and ad hoc performance reporting, dashboards, and advanced analytics.
+ Ability to meet/exceed established key milestones related to assigned major projects.
+ Quality/timeliness of insight generation and development of actionable recommendations based on feedback from key customers and cross-functional colleagues.
+ Management of projects within approved operating budget, with a focus on performing tasks internally whenever possible, rather than outsourcing or delegating to other internal resources.
**Organizational Context:**
+ Reports to the Director, Brand Analytics.
+ This position requires extensive collaboration across the global Commercial Insights GCA team. This role will also have broad global exposure as they partner with cross-functional colleagues (Marketing, Sales, Finance, Data Strategy/Data Engineering, Sales Operations (where applicable) and IS) within global functions and priority Commercial Divisions/markets. Additional collaboration is required with co-promotion partners (if applicable).
**Qualifications Required:**
+ Master's in Data Science, Statistics, Computer Science, or a related field.
+ Minimum 6 years of analytics/data science experience with a focus on omnichannel analytics and demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Strong proficiency in coding language (e.g. SQL, R and/or Python).
+ Proficiency in machine learning techniques, statistical analysis, and data visualization, including classification models, promotion response modeling, predictive modeling, etc.
+ Strong knowledge of omnichannel concepts and data sources, e.g., impressions/click data, web data, etc.
+ Strong understanding of digital marketing media and promotional tactics within Pharma space.
+ Experience working with Google Analytics or Adobe Analytics.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
**Preferred:**
+ Pharmaceutical industry experience.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence).
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense.
+ Experience working with global partners.
+ Knowledge of the global healthcare landscape including different access models.
+ Knowledge of other healthcare data sources such as patient-level data.
_Flexible grade level based on candidate background and skillset_
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**#LI-LN2**
Category Strategic Insights & Analytics
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.
5
Global Safety Officer, Oncology
Markham, Ontario
Astellas Pharma
Posted 28 days ago
Job Viewed
Job Description
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope**
Global Safety Officer is accountable for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading PV Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies for assigned products.
**Essential Job Duties**
+ Leads PV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile.
+ Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator's Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV.
+ Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Safety Science.
+ Responsible and accountable for the risk management of assigned Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science.
+ Responsible and accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
+ Responsible and accountable for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 - Phase 3 clinical trials and Post-Authorization Studies.
**Required Qualifications**
+ Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred);
+ Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor's or master's degree, in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.
+ In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
**Preferred Qualifications**
+ M.D. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
#LI-SS
Category Medical Safety Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope**
Global Safety Officer is accountable for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading PV Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies for assigned products.
**Essential Job Duties**
+ Leads PV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile.
+ Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator's Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV.
+ Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Safety Science.
+ Responsible and accountable for the risk management of assigned Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science.
+ Responsible and accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
+ Responsible and accountable for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 - Phase 3 clinical trials and Post-Authorization Studies.
**Required Qualifications**
+ Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred);
+ Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor's or master's degree, in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.
+ In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
**Preferred Qualifications**
+ M.D. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
#LI-SS
Category Medical Safety Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.
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6
Oncology Brand Analytics Partner
Markham, Ontario
Astellas Pharma
Posted 28 days ago
Job Viewed
Job Description
**Oncology Brand Analytics Partner (12358)**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
**Purpose:**
The Manager, Brand Analytics plays a critical role in providing valuable strategic business insight and actionable recommendations to global and priority Commercial Division/markets to support achievement of brand objectives for priority/strategic products. This position is responsible for assessing brand performance on an ongoing and ad hoc basis to identify new business opportunities and insights and advise key stakeholders on how best to leverage the opportunities. In addition to providing sound counseling and objective interpretation of data to the stakeholders in global and regional commercial functions.
This position will support brand-aligned analytics priorities at a global and a Commercial Division/country level. This position will work across the global and Commercial Division (CD) strategic business partners including Marketing, Health Systems, IS and co-promotion partners (if applicable).
This role will require close collaboration with Commercial Insights (CI) counterparts, when appropriate, to ensure global alignment and consistency.
**Responsibilities and Accountabilities:**
+ Establish strategic direction of team and ensure alignment with global objectives, Commercial Division commercial business needs and overall department objectives.
+ Collaborate with global and CD Marketing and CI GCA functions to enhance global alignment, prioritize high-impact reporting metrics around brand objectives to support better and more informed business decisions.
+ Drive strong cross-functional communication to promote brand-level knowledge sharing and integration of key learnings.
+ Conduct brand-related strategies, opportunity discovery and investment decisions with advanced analytics (examples include Customer Segmentation, Patient Adherence Analysis, HCP Network Analysis, etc) to uncover new business opportunities and insights.
+ Advise global, regional and local stakeholders and provide actionable strategic recommendations that are rooted in a strong understanding of business and brand context.
+ Collaborate with other operational stakeholders to define, develop and maintain business rules in alignment with internal policies and business needs.
+ Identify, standardize and automate integration of critical reporting metrics and modeling tools to address brand-specific needs. Adapt current reports and metrics to support evolving business needs and opportunities; provide consultation and training on reports to ensure their use and effectiveness with users.
+ Develop, define and lead prioritized ad hoc analysis as needed to support evolving business requirements and to provide timely business insights.
+ Manage projects to include efficient resource mobilization, vendor selection, definition of scope and requirements, and achievement of timelines, budgets & deliverables.
+ Support recommendations on various statistical modeling techniques to apply within analytical projects and mentor others on the use and application of those modeling techniques.
+ Maintain proficiency among data systems, programs, and software resources (e.g. AWS Redshift and SQL), to ensure optimal and efficient achievement of department objectives.
+ Develop comprehensive understanding of various data sources, including patient-level data, as well as their appropriate applications, to facilitate rigorous analytic process design and reliable business insights generation
**Qualifications Required:**
+ Bachelor's degree in business-related field.
+ Minimum 4 years of pharmaceutical analytics, operations or related experience required that includes data analysis and reporting, or four years with Masters degree and related experience required, with demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Proficiency in coding language (e.g. SQL, SAS, R, or Python)
+ Working knowledge of various statistical modeling techniques and their application within complex analytical projects, e.g., regression modeling, promotion response modeling, ROI, natural language processing, predictive modeling, etc.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
**Qualifications Preferred:**
+ Pharmaceutical industry experience.
+ Working knowledge of commercial data sources, e.g., Symphony patient claims data and sub-national data, IQVIA NPA data.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence)
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense
+ Sound experience with data visualization.
+ Experience working with global partners
+ Knowledge of the global healthcare landscape including different access models
**Working Environment:**
+ This position is based in Canada and will not require on-site work. However, there may be occasional travel to Northbrook office required.
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-LN2
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
**Purpose:**
The Manager, Brand Analytics plays a critical role in providing valuable strategic business insight and actionable recommendations to global and priority Commercial Division/markets to support achievement of brand objectives for priority/strategic products. This position is responsible for assessing brand performance on an ongoing and ad hoc basis to identify new business opportunities and insights and advise key stakeholders on how best to leverage the opportunities. In addition to providing sound counseling and objective interpretation of data to the stakeholders in global and regional commercial functions.
This position will support brand-aligned analytics priorities at a global and a Commercial Division/country level. This position will work across the global and Commercial Division (CD) strategic business partners including Marketing, Health Systems, IS and co-promotion partners (if applicable).
This role will require close collaboration with Commercial Insights (CI) counterparts, when appropriate, to ensure global alignment and consistency.
**Responsibilities and Accountabilities:**
+ Establish strategic direction of team and ensure alignment with global objectives, Commercial Division commercial business needs and overall department objectives.
+ Collaborate with global and CD Marketing and CI GCA functions to enhance global alignment, prioritize high-impact reporting metrics around brand objectives to support better and more informed business decisions.
+ Drive strong cross-functional communication to promote brand-level knowledge sharing and integration of key learnings.
+ Conduct brand-related strategies, opportunity discovery and investment decisions with advanced analytics (examples include Customer Segmentation, Patient Adherence Analysis, HCP Network Analysis, etc) to uncover new business opportunities and insights.
+ Advise global, regional and local stakeholders and provide actionable strategic recommendations that are rooted in a strong understanding of business and brand context.
+ Collaborate with other operational stakeholders to define, develop and maintain business rules in alignment with internal policies and business needs.
+ Identify, standardize and automate integration of critical reporting metrics and modeling tools to address brand-specific needs. Adapt current reports and metrics to support evolving business needs and opportunities; provide consultation and training on reports to ensure their use and effectiveness with users.
+ Develop, define and lead prioritized ad hoc analysis as needed to support evolving business requirements and to provide timely business insights.
+ Manage projects to include efficient resource mobilization, vendor selection, definition of scope and requirements, and achievement of timelines, budgets & deliverables.
+ Support recommendations on various statistical modeling techniques to apply within analytical projects and mentor others on the use and application of those modeling techniques.
+ Maintain proficiency among data systems, programs, and software resources (e.g. AWS Redshift and SQL), to ensure optimal and efficient achievement of department objectives.
+ Develop comprehensive understanding of various data sources, including patient-level data, as well as their appropriate applications, to facilitate rigorous analytic process design and reliable business insights generation
**Qualifications Required:**
+ Bachelor's degree in business-related field.
+ Minimum 4 years of pharmaceutical analytics, operations or related experience required that includes data analysis and reporting, or four years with Masters degree and related experience required, with demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Proficiency in coding language (e.g. SQL, SAS, R, or Python)
+ Working knowledge of various statistical modeling techniques and their application within complex analytical projects, e.g., regression modeling, promotion response modeling, ROI, natural language processing, predictive modeling, etc.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
**Qualifications Preferred:**
+ Pharmaceutical industry experience.
+ Working knowledge of commercial data sources, e.g., Symphony patient claims data and sub-national data, IQVIA NPA data.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence)
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense
+ Sound experience with data visualization.
+ Experience working with global partners
+ Knowledge of the global healthcare landscape including different access models
**Working Environment:**
+ This position is based in Canada and will not require on-site work. However, there may be occasional travel to Northbrook office required.
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-LN2
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.
7
Oncology Development Physician (Medical Director)
Markham, Ontario
Astellas Pharma
Posted 7 days ago
Job Viewed
Job Description
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Ontario, Canada. Remote work from Ontario may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
+ Responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group.
+ Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and execution of assigned trials.
+ Clinical team leader with clear understanding of areas of responsibilities and accountabilities of the role. Team player who is comfortable in situations where the role serves as a consultant and support to other functions and particularly the asset area. Understands the criticality of information and knowledge management, partnership and collaboration required in drug development.
**Essential Job Responsibilities:**
+ Collaborates effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials. Serves as Medical Monitor w/ responsibility for safety monitoring.
+ Ensures patient safety on clinical study is maintained. Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
+ Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
+ Coordinates with Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents.
+ Able to assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs.
+ Responsible for managing the process of development of protocol and necessary regulatory documents.
+ Accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy.
+ In late phase program serves as the Lead for an indication specific clinical development team and is responsible and accountable for both strategy and execution of the clinical development plan for that indication or line of therapy.
+ In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program.
+ Acquires public knowledge regarding therapeutic landscape, potential competitor products and serves as clinical voice regarding the potential for impact on planned clinical, medical affairs and commercial strategies.
+ Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate. Serve as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders. Serves as the clinical interface in regulatory authority interactions.
+ Accountable for clinical development milestones for their given trials. Supports Medical lead and Asset team at governance meetings and can present the clinical development plan in a succinct and clear manner at such meetings.
+ Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies.
+ Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. Accountable for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory.
+ Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets.
+ Supports clinical development related initiatives as needed. Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
**Qualifications:**
**Required**
+ MD or MD/PhD with oncology fellowship complete. Board certified with patient treatment experience beyond fellowship preferred.
+ Must have 5 years of pharmaceutical industry or academia experience specifically in clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company.
+ Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.
+ Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.
+ Excellent verbal and written communication skills in English.
+ Experience working in global teams and a global matrixed, remote working environment.
+ Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
+ Highest level of scientific integrity and impeccable work ethics
**Preferred:**
+ Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors
+ Prior clinical research experience in an academic setting
+ Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.
+ Direct experience leading global regulatory marketing authorization submissions and defense of those submissions
**Salary Range**
$220K - $290K (NOTE: Final salary could be more or less, based on experience)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Ontario, Canada. Remote work from Ontario may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
+ Responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group.
+ Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and execution of assigned trials.
+ Clinical team leader with clear understanding of areas of responsibilities and accountabilities of the role. Team player who is comfortable in situations where the role serves as a consultant and support to other functions and particularly the asset area. Understands the criticality of information and knowledge management, partnership and collaboration required in drug development.
**Essential Job Responsibilities:**
+ Collaborates effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials. Serves as Medical Monitor w/ responsibility for safety monitoring.
+ Ensures patient safety on clinical study is maintained. Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
+ Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
+ Coordinates with Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents.
+ Able to assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs.
+ Responsible for managing the process of development of protocol and necessary regulatory documents.
+ Accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy.
+ In late phase program serves as the Lead for an indication specific clinical development team and is responsible and accountable for both strategy and execution of the clinical development plan for that indication or line of therapy.
+ In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program.
+ Acquires public knowledge regarding therapeutic landscape, potential competitor products and serves as clinical voice regarding the potential for impact on planned clinical, medical affairs and commercial strategies.
+ Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate. Serve as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders. Serves as the clinical interface in regulatory authority interactions.
+ Accountable for clinical development milestones for their given trials. Supports Medical lead and Asset team at governance meetings and can present the clinical development plan in a succinct and clear manner at such meetings.
+ Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies.
+ Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. Accountable for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory.
+ Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets.
+ Supports clinical development related initiatives as needed. Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
**Qualifications:**
**Required**
+ MD or MD/PhD with oncology fellowship complete. Board certified with patient treatment experience beyond fellowship preferred.
+ Must have 5 years of pharmaceutical industry or academia experience specifically in clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company.
+ Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.
+ Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.
+ Excellent verbal and written communication skills in English.
+ Experience working in global teams and a global matrixed, remote working environment.
+ Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
+ Highest level of scientific integrity and impeccable work ethics
**Preferred:**
+ Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors
+ Prior clinical research experience in an academic setting
+ Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.
+ Direct experience leading global regulatory marketing authorization submissions and defense of those submissions
**Salary Range**
$220K - $290K (NOTE: Final salary could be more or less, based on experience)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.
8
Senior Clinical Research Associate - Oncology/Cross TA - (Toronto / Field Based)
Toronto, Ontario
ICON Clinical Research
Posted today
Job Viewed
Job Description
As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Toronto Canada
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Oncology monitoring experience is required
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1.
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans Toronto canadien
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 3 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Une experience de la surveillance de l'oncologie est requise
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
En tant qu'ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l'intelligence en santé.
**What You'll Be Doing:**
+ Serve as the primary point of contact between investigational sites and the sponsor
+ Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
+ Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
+ Maintain up-to-date documentation in CTMS and eTMF systems
+ Support and track site staff training and maintain compliance records
+ Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
+ Support subject recruitment and retention efforts at the site level
+ Oversee drug accountability and ensure proper storage, return, or destruction
+ Resolve data queries and drive timely, high-quality data entry
+ Document site progress and escalate risks or issues to the clinical team
+ Assist in tracking site budgets and ensuring timely site payments (as applicable)
+ Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Toronto Canada
+ Eligible to work in Canada without visa sponsorship
+ A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
+ Oncology monitoring experience is required
+ Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1.
+ A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
+ Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
+ Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
+ A clear communicator, problem-solver, and collaborative team player
+ Willing and able to travel approximately 50% for on-site monitoring visits
**Vous êtes:**
+ Basé(e) dans Toronto canadien
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 3 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Une experience de la surveillance de l'oncologie est requise
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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.
This advertiser has chosen not to accept applicants from your region.
9