The Sr. Manager – Associate Director, Clinical Supply Chain is responsible for managing and ensuring timely supply of clinical trial materials for clinical studies at all stages of development. Responsibilities include cross functional planning for clinical demand and forecasting, management of supply chain vendors, inventory management at depots and sites, order management, import and export of GMP drug substance and drug product, returns and destruction.
Duties and Responsibilities
• Support labelling & packaging operations for clinical studies (Phase 1, 2 and 3)
• Coordinate and manage distribution of Investigational products to depots and sites for clinical studies
• Manage clinical packaging/distribution vendors including negotiating contracts, reviewing batch documentation, designing and developing the distribution instructions
• Participate in the setup, testing and maintenance of IWRS systems.
• Serve as the interface between the CMC and clinical teams to ensure smooth conduct of clinical studies.
• Review departmental SOPs and ensure compliance with industry standards
• Coordinate import and export of GMP materials.
• Maintain inventory database, systems and documentation related to material receipt, storage and distribution in compliance with regulatory requirements.
• Ensure compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory requirements