Description
Provide leadership and oversight of site monitoring activities across assigned clinical studies to ensure delivery in line with quality, timelines, and budget.Drive execution of Takeda’s site monitoring strategy, including Risk-Based Monitoring (RBM/RBQM) approaches and internalized monitoring capabilities.Ensure compliance with ICH-GCP, local regulatory requirements, and Takeda SOPs across all site monitoring activities.Lead and develop a high-performing team and/or oversee CRO site monitoring performance to support efficient clinical trial delivery.Site Monitoring Oversight & Delivery
Oversee planning and execution of site monitoring activities including Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, and Monitoring Oversight Visits.Ensure study-specific site monitoring plans are developed, approved, and executed using Takeda standards and systems.
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