Clinical Study Start Up Manager
On-siteMontréal, Quebec, Canada
Job Summary
Oversee the collection, review, and tracking of essential site documents for study activation, ensuring all materials are filed correctly and maintained in an inspection-ready state within the Trial Master File. Collaborate with the Regulatory team to prepare comprehensive submission packages for Health Authorities, Research Ethics Boards, and Institutional Review Boards, while adapting Informed Consent Forms to align with local requirements. Support site identification, feasibility assessment, and qualification to ensure the selection of high-performing clinical research sites, serving as the primary Sponsor point of contact for clinical site staff, investigators, and external CRO start-up leads. Facilitate the negotiation of Clinical Trial Agreements and budgets by partnering with legal, finance, and management teams to resolve bottlenecks. Track regulatory submission and approval statuses globally, promptly addressing queries from health authorities and ethics committees. Requires 8+ years of clinical research experience, strong knowledge of ICH-GCP guidelines, and bilingualism (English and French). Base salary plus equity, annual bonus, and a CAD $1,500 annual Active Lifestyle Allowance.
Required Qualifications
- Bachelor's degree (BSc) in Life Sciences, Nursing, or a related field
- 8+ years of clinical research experience
- experience within a pharmaceutical, biotech, or CRO environment
- strong working knowledge of ICH-GCP guidelines
- familiarity with Health Canada regulations
- familiarity with the Canadian clinical trial regulatory landscape
- highly organized
- keen attention to detail
- proactive, problem-solving mindset
- ability to manage multiple competing priorities effectively
- exceptional written and verbal communication skills
Desired Qualifications
- deep, specialized knowledge of study start-up milestones
- knowledge of local/global regulatory pathways
- knowledge of ethics submissions
- knowledge of contract/budget frameworks
- direct, hands-on experience managing clinical study start-up and site activation activities
- bilingualism (English and French)
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