Job Title

Freelance CTM/LCRA - Canada - Vaccines/Infectious DiseasesUpsilon Global are seeking an experienced Freelance Clinical Trial Manager / Lead CRA who's also happy to perform monitoring visits in a hybrid role for a real-world evidence, vaccine effectiveness study.This will be approximately 0.4-0.5 FTE, covering 3 key sites for RWE in a good epidemiological practice setting. Start-up, regulatory and monitoring activities will be required, so a strong knowledge EC processes and Canadian submissions is essential, along with a willingness to travel for approximately 4 IMVs per site over the duration of the 12-month study.Key information:Position: Freelance CTM/LCRAEmployment: FreelanceFTE: 1.0 FTEIndication: Infectious Disease/VaccinesStart Date: January 2026Duration: Initial 12 month contractTravel: Up to 12 IMVs requiredLocation: Remote/fully homebasedKey Responsibilities:Lead study start-up 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 start-up, 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 start-up and potential conduct phases.Organize sites in Veeva CTMS (e.g., updating milestones and start-up 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 start-up 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 engagementFor more details please apply or contract +44 203 875 9966 to register your interest.