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The Senior Manager, R&D Data Stewardship (Clinical & Clinical Operations) is a critical role within a newly created TES (Technology Enabled Sciences) - Data Excellence (DE) group with Center of Excellence (COE) for Data stewardship. This role bridges clinical operations strategy, regulatory compliance, and enterprise data architecture to ensure clinical trial data is FAIR (Findable, Accessible, Interoperable, Reusable), AI-ready, and strictly governed. Acting as the definitive stewardship voice for clinical data, this individual will partner cross-functionally to enforce data standards (eg,... more ->
The Opportunity: Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities). Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and continuous improvement, ensuring adherence to GLP/GCP/GMP, data integrity and applicable regulations. Partner with Nonclinical Development, Procurement, Legal and IT. The Role: Vendor Lifecycle and Governance: Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance... more ->