The Clinical Supply Operations Specialist supports the Clinical Drug Supply assess risks, stocking levels, and trends to maintain supply continuity.
Execute and document Accountability, Reconciliation, Returns, and Destruction (ARRD) in alignment with procedures and audit expectations.
Maintain internal systems for lot creation, batch status updates, and inventory maintenance; ensure data integrity and traceability.
Coordinate IP shipments, including system- and non-system-generated orders and depot transfers; supervise progress and resolve issues.
Lead temperature excursion assessments, documentation, and follow-up actions in collaboration with QA/QP and vendors.
Develop and maintain Expected Document Lists (EDLs); handle eTMF content to ensure TMF completeness per regulatory requirements.
Support QA/QP release management; perform pack-and-label kit and sequence reconciliation activities.
Lead or support inspection readiness activities; maintain documentation and controls for audit preparedness.
Implement IRT management tasks including alert triage/response, UAT planning and execution, and data change controls.
Contribute to suspected serious non-compliance investigations and corrective actions under defined procedures.
Partner cross-functionally with Clinical Operations, Quality/QA/QP, CMC, depots, couriers, and CROs/partners to align on priorities.
Detail operational activities, track KPIs and leading indicators, and supply insights to continuous improvement initiatives.
This Role Might Be for You If You Have Hands-on experience with clinical IP supply chain operations, including distribution, inventory control, ARRD, and temperature excursion management.
Solid understanding of IRT/RTSM and eTMF processes, including alert management and UAT, plus familiarity with inventory/ERP or WMS tools.
Solid understanding of GxP/GDP expectations and regulatory considerations for clinical supplies and documentation.
Strong attention to detail, documentation rigor, and a quality-first approach.
Ability to tackle moderate problems within established procedures and to prioritize across multiple studies and collaborators.
Clear, proactive communication and collaboration skills across internal teams and external vendors/CROs.
Proficiency with Microsoft Excel, Word, and PowerPoint; comfort analyzing data and building status reports.
Flexibility to support time-sensitive shipments and operational needs across global time zones as needed.
To Be Considered Bachelor's degree in life sciences or a related field.
2 + years of relevant experience supporting clinical drug supply and logistics in a sponsor, CRO, or vendor environment.
Experience supporting multi-therapy area and/or global studies is advantageous; additional languages are a plus.