Overview
The Clinical Trials Supply Manager will play a critical role in a dynamic biotech environment, managing supply chain operations for clinical trials. This position involves close collaboration with internal Clinical Operations and CMC/Drug Supply teams, ensuring efficient delivery of investigational medicinal products (IMPs) to trial sites globally. The role is tailored for an experienced professional capable of aligning clinical requirements with supply chain strategies.
Responsibilities
- Collaborate with Clinical Operations to monitor recruitment rates and site demand.
- Lead the management of primary and secondary packaging operations.
- Develop and optimize demand forecast models based on trial protocols.
- Direct daily operations with secondary packaging partners and logistics providers.
- Support IRT/RTSM system configuration and user-acceptance testing.
- Manage execution of cold chain logistics and oversee import/export documentation.
- Ensure compliance with cGMP/cGCP standards throughout the supply process.
- Act as the operational liaison between various functional teams and external partners.
Requirements
- Minimum of 5 years of experience in Clinical Trial Supply Chain management within Pharma, Biotech, or CDMO.
- Proven track record of cross-functional collaboration with Clinical Operations and CMC teams.
- Extensive experience in executing Packaging & Labelling campaigns for global clinical trials.
- Solid understanding of cGMP, cGCP, Annex 13, and global regulatory requirements for investigational medicinal products.
- Familiarity with IRT/RTSM system configuration and logistics management.
- Ability to work flexibly in a fast-paced biotech setting.
- Excellent problem-solving and strategic thinking skills.
- Demonstrated capacity to manage multiple priorities effectively.