Your mission
As (Senior) Clinical Trial Supply Manager, you will ensure the timely and reliable supply of investigational medicinal products (IMPs) and associated materials to patients participating in our clinical trials. You will manage end-to-end clinical supply execution — from forecasting and packaging through distribution and returns — working closely with CDMOs, TechOps, Clinical Operations, QA, Regulatory, and Finance to ensure seamless study delivery.
Key Responsibilities
- Clinical Supply Execution
- Translate study requirements into operational supply and distribution plans.
- Manage demand and supply planning to ensure continuous and compliant IMP availability.
- Oversee packaging, labeling, QP release, distribution, and returns/destruction activities.
- Act as IRT system owner for supply chain (study setup, shipments, drug assignment, etc.).
- Vendor & CDMO Management
- Lead day-to-day CDMO project coordination, including regular calls and timeline tracking.
- Monitor packaging/labeling progress, batch documentation, release, and distribution.
- Manage distribution plans, logistics schedules, and timely issue resolution.
- Define, implement, and maintain SOPs and compliant processes.
- Drive vendor performance through structured governance and proactive communication.
- Logistics & Distribution
- Coordinate IMP, QC/stability sample, and DS-DP transfers and imports worldwide.
- Serve as point of contact for clinical-site shipment queries and troubleshooting.
- Define, implement, and maintain logistics SOPs and compliant processes.
- Ensure adherence to GDP and import/export requirements.
- Governance & Cross-Functional Collaboration
- Represent Supply in study, program, and vendor governance meetings.
- Align closely with TechOps, Clinical Operations, Regulatory, QA, and Finance on study readiness and execution.
- Track and report key supply metrics; identify and drive process improvements.
- Administrative & Other Duties
- Manage storage and transport insurance coverage.
- Review, approve, and track supplier invoices; ensure budget adherence.
- Contribute to continuous improvement initiatives and support evolving priorities.