Description
Tasks:
- Lead study startup in Canada, including updating study documents (e.g., Informed Consent Form ) to align with Canadian regulatory and EC requirements.
- Compile and manage submission packages for Health Canada and EC approvals.
- Handle contract negotiations with sites, including serving as the primary point of contact.
- Support site management during startup, ensuring timely SIV preparation and execution.
- If budget is secured post-SIV, transition to monitoring: conduct monitoring visits (up to 4 per site, based on recruitment) and remote visits (1/month/site).
- Ensure timely reporting, communication with Data Manager (DM) and broader project team, and transparent issue escalation.
- Maintain Investigator Site File (ISF) and Site Master File (SMF) completeness throughout startup and potential conduct phases.
- Organize sites in Veeva CTMS (e.g., updating milestones and startup trackers).
- Support site invoicing by confirming documentation completeness and following up until invoices are received.
- Proactively resolve site and regulatory issues autonomously, stepping beyond traditional CRA/PM duties (e.g., assisting with DM or cross-team tasks).
- Collaborate with the team to find resolutions, and elevate team performance through supportive contributions.
Requirements:
- Based in Canada with strong familiarity in Canadian EC processes and regulatory submissions (e.g., Health Canada IND/NDS pathways).
- Fluent in English; French proficiency preferred for Quebec or bilingual sites.
- Minimum 5+ years of experience as a Senior CRA or PM in RWD/epidemiological studies, with proven expertise in startup activities.
- Willingness to travel domestically for SIVs, monitoring visits, and meetings as needed.
- Proficiency in Veeva CTMS and Microsoft Office suite; experience with GEP guidelines.
- Excellent organizational skills, with the ability to manage multiple priorities in a fast-paced, remote-hybrid environment.
- Strong negotiation and communication skills for stakeholder engagement
