Project Manager II, Early Phase (Canada)
Core
End-to-end management of Phase I and Phase II clinical trials, ensuring compliance with GCP, regulatory requirements, and study timelines/budgets. (via careerplan.io/jobs/15-003-7C-F6F-project-manager-ii-early-phase-canada-at-indero)
Role type
Senior clinical trial project manager (early phase)
Builds
Clinical trial operations and deliverables for sponsors
Domain
Clinical research / Biopharmaceuticals
Required skills
Clinical trial project management, GCP/ICH/FDA/Health Canada regulations, vendor management, budget tracking, risk mitigation, site selection and activation, data management coordination, regulatory affairs collaboration, training matrix management, recruitment performance tracking
Preferred skills
Dermatology clinical trial experience, bilingualism (English/French), mentorship of junior staff, business development participation
Technologies
Microsoft Office Suite
Responsibilities
Lead study start-up activities including TMF setup, site contracting, and vendor onboarding; Monitor and control study budgets and timelines; Coordinate with sponsors, clinical sites, and cross-functional teams; Ensure compliance with GCP and regulatory requirements; Track recruitment performance and develop mitigation plans; Oversee quality of project deliverables and study documentation; Provide project-specific training to CRAs
Seniority
Senior, hands-on IC