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1. Overall Study Leadership
Own the day-to-day management of the global clinical studyLead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)Ensure alignment between global strategy and regional executionDrive study timelines, milestones, and deliverables
2. Study Planning and Execution
Develop and maintain:study timelinesoperational plansrisk management plansenrollment strategies
Oversee country start-up, site activation, recruitment, monitoring, and closeoutEnsure protocol execution is consistent globally
3. Vendor and CRO Oversight
Manage external vendors and CRO partnersTrack performance metrics and service qualityResolve operational issues and escalationsEnsure vendors meet contractual obligations and timelines...