Project Manager II / Gestionnaire de projet II (Canada)
Core
Manage the full lifecycle of clinical trials (initiation, planning, execution, monitoring, closure) for a mid-sized CRO, ensuring compliance with GCP, regulatory requirements, budget, and timelines.
Role type
Senior clinical trial project manager (Phase I-III)
Builds
Clinical study deliverables including study plans, protocols, eCRFs, clinical study reports, and TMFs for multisite global Phase III projects.
Domain
Clinical research / Biopharmaceuticals
Required skills
Clinical trial project management, GCP/ICH standards, regulatory compliance, budget control, risk management, stakeholder communication, team leadership, multi-center trial coordination
Preferred skills
Dermatology and/or rheumatology trial experience, managing budgets over $3M USD, French language proficiency
Technologies
Microsoft Office suite
Responsibilities
Serve as primary contact for the Sponsor; lead study start-up activities including site selection, activation, and contracting; manage project budget and timelines; ensure audit readiness and quality of study deliverables; lead the core project team including coordinators and assistants; coordinate with functional departments (Regulatory, Data Management, Clinical Monitoring, Biostatistics).