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

K-Recruiting Life Sciences

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