• Lead IRT strategy during protocol development and study start-up. • Translate protocol requirements into IRT functional specifications in collaboration with functional leads. • Partner with Clinical Supply Chain to define inventory strategy within IRT, including buffer, overage, resupply thresholds, and expiry management. • Ensure packaging configuration is accurately reflected in the IRT system. • Own and govern all IRT enhancements and system request changes after go-live. • Assess the operational, site, and supply chain impact of proposed changes. • Act as a cross-functional impact assessor between Clinical Team, Supply Chain, QA, and IRT vendor. • Create and maintain a data change or systems change requests log and governance model to ensure inspection readiness. • Serve as the primary liaison with the IRT vendor. • Review and approve all necessary specifications with the internal team. • Lead User Acceptance Testing (UAT) and validation activities in partnership with Quality Assurance. • Govern change orders and mid-study updates. • Manage all IRT manuals with vendors and ensure effective rollout to study teams. • Monitor live study IRT performance. • Troubleshoot IRT-driven shipment and inventory issues, and collaborate with the vendor for resolution. • Act as the escalation point for site issues related to IRT. • Initiate deviations and/or CAPAs as required. • Prevent protocol deviations and missed dosing due to IRT misunderstandings or misalignments. • Align Clinical Operations, Clinical Supply Chain, Biostatistics, Data Management, and Clinical Development teams on IRT design. • Manage IRT training. • Establish an IRT governance model and best practices across trials. • Utilize data analytics tools to monitor supply chain performance and identify improvement areas. • Ensure IRT documentation supports FDA/EMA inspection readiness. • Maintain audit trails, validation documentation, and SOP alignment. • Ensure compliance with all relevant regulations and standards related to supply chain operations, including GMP and FDA requirements. • Identify potential risks within the supply chain and develop mitigation strategies. • Perform other job-related duties as assigned by management, within the reasonable scope of this position.