Associate Director, Site Monitoring

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 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. Oversee planning and execution of monitoring activities (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits) and ensure study-specific monitoring plans are developed and executed per Takeda standards. Manage CRO monitoring activities, assess trends, and drive risk mitigation. Act as functional leader for site monitoring, collaborate with cross-functional teams, and contribute to start-up, execution, and close-out phases. Drive RBQM principles and continuous improvement in monitoring; ensure training and development of Site Monitors and Leads; maintain inspection readiness and quality in TMF, CTMS, and EDC systems. Benefits from global collaboration, budget forecasting, and process improvements; requires strong regulatory knowledge, risk-based monitoring experience, and leadership in biotech/pharma/CRO environments.