Lead transformative clinical trials at AbCellera in Montréal, Québec. This role requires proven experience in clinical study oversight, ensuring compliance and excellence in execution for breakthrough medicines.
As a Clinical Study Manager, you will spearhead clinical trials from initiation to completion, collaborating with cross-functional teams. You'll ensure adherence to regulatory requirements while managing project budgets and timelines. Your strong organizational skills will be key as you handle study planning, execution, and data integrity throughout the process.
Key Responsibilities:
• Oversee global strategy for clinical trials, including planning and monitoring
• Ensure compliance with Good Clinical Practice (GCP) and study protocols
• Develop and review study plans, protocols, and related documents
• Manage timelines, milestones, and budgets to meet deliverable deadlines
• Monitor safety protocols, addressing participant welfare issues
Requirements: