Manager, Clinical Supply – IRT

Role Overview

• 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.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• At least 5 years of experience in clinical trials, with a minimum of 3 years of direct IRT experience.
• Strong understanding of clinical supply chain operations.
• Experience with global, multi-depot studies.
• Independent self-starter, able to lead ad-hoc teams, work without supervision, and exercise good judgment in determining objectives and approaches to assignments.
• Systems thinking across Clinical Operations, Sites, and Supply Chain.
• Ability to translate protocol into operational and site-friendly logic.
• Strong vendor management and technical documentation skills.
• Risk-based thinking for inventory and enrollment variability.
• Expertise in managing IRT data changes and site issues without operational disruption.