Trial Start up Manager (Bilingual English / French Mandatory)
Mississauga, Ontario, CA
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Study Start‑Up Manager (Bilingual English / French Mandatory)
Location: Canada, Home based
About the role
We are expanding our Clinical Research team and are looking for a Study Start‑Up Manager to support clinical trials across Canada.
This is an individual contributor role with end‑to‑end responsibility for study start‑up and regulatory submission activities at country and site level, ensuring timely activation and full regulatory compliance.
The role will act as a key point of contact with Ethics Committees across Canada, requiring strong knowledge of federal and provincial regulations, including Quebec.
Key responsibilities
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Lead and manage study start‑up activities and regulatory submissions for assigned clinical trials at country and site level.
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Prepare, review and submit dossiers to Health Authorities, IRBs and Ethics Committees across different Canadian provinces.
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Manage Informed Consent Forms (ICFs), including French versions, and coordinate updates requested by ECs or HAs.
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Coordinate site activation activities, including green‑light readiness and regulatory milestones.
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Maintain accurate documentation and tracking in CTMS and eTMF systems.
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Collaborate closely with internal cross‑functional teams, vendors and external stakeholders.
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Proactively identify and mitigate regulatory or start‑up risks.
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Ensure compliance with ICH‑GCP, local regulations and internal SOPs.
Must‑have requirements
To be successful in this role, candidates must meet the following criteria:
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Strong hands‑on experience with Canadian regulations, including federal and provincial requirements.
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Direct experience managing clinical trials at country level in Canada (not global‑only exposure).
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Solid experience with IRB submissions and Ethics Committee interactions across multiple provinces.
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Bilingual English and French (mandatory), including ability to:
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Proven clinical trials background with experience in:
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Experience working within a Sponsor or CRO environment, with ability to manage complex workloads.
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Bachelor’s degree in Life Sciences, Pharmacy or a related field.
Nice to have
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Flexibility in years of experience, as long as strong hands‑on clinical and regulatory expertise is demonstrated.
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Experience across different areas of clinical operations, regulatory or study start‑up, with transferable skills.
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Advanced degree in a life sciences‑related field.
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Experience supporting multiple trials simultaneously in a fast‑paced environment.
About the department
Our department in Canada is dedicated to running all clinical development activities, from initial planning of clinical trials to authority submission. Our team supports trial execution by aligning processes, developing competencies, sharing knowledge, and providing training across trial management and medical staff. Join us in a fast-paced and dynamic environment where your contributions will make a significant impact.