Trial Start up Manager (Bilingual English / French Mandatory)

Job description

. 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: Lead and manage study start ‑ up activities and regulatory submissions for assigned clinical trials at country and site level. Prepare, review and submit dossiers to Health Authorities, IRBs and Ethics Committees across different Canadian provinces. Manage Informed Consent Forms (ICFs) , including French versions, and coordinate updates requested by ECs or HAs. Coordinate site activation activities, including green ‑ light readiness and regulatory milestones. Maintain accurate documentation and tracking in CTMS and eTMF systems. Collaborate...