Project Manager II, Early Phase (Canada)
Core
End-to-end management of Phase I and Phase II clinical trials, ensuring compliance with budgets, timelines, and regulatory standards while coordinating cross-functional teams and external stakeholders. (via careerplan.io/jobs/15-003-7C-F6F-project-manager-ii-early-phase-canada)
Role type
Senior clinical trial project manager (early phase)
Builds
Clinical trial operations and deliverables for pharmaceutical and biotech sponsors
Domain
Clinical research / Life sciences
Required skills
Clinical trial project management, vendor management, budget tracking, risk mitigation, site selection and activation, regulatory compliance (GCP/ICH/FDA), stakeholder communication, data management coordination, quality assurance audit response
Preferred skills
Dermatology clinical trial experience, bilingualism (English/French), mentoring junior staff, business development support
Technologies
Microsoft Office Suite, Trial Master File (TMF) systems
Responsibilities
Lead study start-up activities including kick-off meetings, TMF setup, site contracting, and vendor onboarding; monitor and control study budgets by tracking hours and managing change orders; track recruitment performance and develop mitigation plans; oversee clinical monitoring activities and CRA training; ensure compliance with GCP, ICH, and local regulations; coordinate with Regulatory Affairs, Data Management, and Clinical Operations; prepare annotated site visit reports and monitoring tools.
Seniority
Senior, hands-on IC with mentorship responsibilities