• Develop and oversee global clinical sample management strategies for assigned Phase 1–3 trials • Lead operational planning for all sample-related activities, including collection, processing, shipping, storage, chain-of-custody, and destruction • Collaborate with Clinical Operations, Clinical Pharmacology/Bioanalysis, Data Management, and Regulatory Affairs to ensure sample plans align with protocol requirements and scientific objectives • Collaborate with Outsourcing and Vendor Governance (OVG) for vendor selection and contracting • Provide oversight of central labs and assigned specialty labs, couriers, and biorepositories • Ensure laboratory manuals and sample handling instructions are complete, clear, and version-controlled • Collaborate with central lab to oversee and monitor sample inventory and tracking systems, ensuring accuracy and regulatory compliance • Establish and maintain internal metrics and KPIs for sample management performance; present regular updates to study teams • Support sample-related sections of protocols, ICFs, and monitoring plans • Drive resolution of sample-related issues, deviations, and CAPAs in collaboration with QA and vendors • Collaborate with Data Management to resolve queries during reconciliation processes • Maintain awareness of evolving global regulations and guidance for biological specimen handling, import/export, and privacy requirements • Provide training and subject matter expertise to internal teams, CROs, and site staff • Contribute to inspection readiness and participate in audits or regulatory inspections as the SME for sample management • Travel as required to support site initiation, vendor audits, and troubleshooting