Lead clinical site activation across Canada using regulatory expertise, CTMS knowledge, and precise document management for Parexel FSP trials. This remote role serves regional sites.
As a Regional Site Start Up II, you will deliver activation activities across clinical trials and address geographic-specific needs. You will coordinate essential documents, regulatory packages, submissions, and timelines while collaborating with sites, sponsors, and internal teams. Your work supports compliant, inspection-ready study start-up.
Key Responsibilities:
- Deliver assigned site activation timelines according to plan
- Gather essential documents and sponsor-specific materials
- Maintain site intelligence and activation updates in CTMS
- Ensure regulatory packages meet country and ICH-GCP requirements
- Troubleshoot regional challenges and escalate activation risks
Requirements:
- Bachelor's Degree minimum education requirement
- Three to four years of relevant experience
- Experience working with the United States and Canada
- Clinical drug development and study start-up experience
- Knowledge of CTMS, TMF, and regulatory guidelines
Apply clinical start-up, regulatory, CTMS, and stakeholder collaboration skills to activate Parexel FSP sites across Canada.
Regional Clinical Site Start-Up Specialist in Ottawa employer: Parexel
At Parexel, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid role in Canada offers employees the flexibility to balance their professional and personal lives while providing ample opportunities for growth and development within the clinical operations field. With a strong commitment to compliance and quality, we empower our team members to make meaningful contributions to clinical trials, ensuring they feel valued and supported in their career journey.
