Description

Freelance CTM/LCRA – Canada – Vaccines/Infectious Diseases

Upsilon 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/LCRA

Employment: Freelance

FTE: 1.0 FTE

Indication: Infectious Disease/Vaccines

Start Date: January 2026

Duration: Initial 12 month contract

Travel: Up to 12 IMVs required

Location: Remote/fully homebased

Key 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 engagement

For more details please apply or contract +44 203 875 9966 to register your interest.