Manager/Sr. Manager, Clinical Supply Management

Employment Type

: Full-Time

Industry

: Miscellaneous



The Position The Manager/Senior Manager, Clinical Supply Management is responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies. This position reports to the Director, Clinical Supply Management. Responsibilities * Collaborate cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance to plan and execute IMP supply planning including labeling and packaging, inventory control, and depot management for assigned clinical studies * Develop, update, and adapt clinical supplies distribution plans based on program and study timelines, trial design, clinical program changes, recruitment, geography, and manufacturing schedules * Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of study execution * Coordinate with Manufacturing Operations, Quality Assurance and Regulatory Affairs to ensure planned IMP release testing/re-testing, stability, expiry dates, labeling and packaging schedules align with program milestones, adjusting as necessary over the course of the program * Develop plans for ancillary supply sourcing and liaise with CMC team to ensure ancillary compatibility with IMP * Develop and manage SOPs, work instructions, processes, systems, and forms governing clinical supplies management in alignment with industry standards and regulatory requirements * Serve as liaison between Clinical Operations and Quality Assurance to manage IMP shelf-life extensions, temperature deviation management, product complaints, and associated investigations * Assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process * Support projects and process improvement efforts related to supply chain management Requirements: * 4-year college degree (relevant discipline preferred) * Minimum of 5 years in clinical supply chain management function * Experience with electronic interactive response technologies for inventory management * Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and global distribution * Solid vendor management skills * Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner * Proficient in MS Office (Word, Excel, and PowerPoint) * Ability to work in a team or independently * Effective interpersonal, written, and verbal communication skills * Able to critically evaluate and prioritize job tasks and the impact on overall study execution * Strong problem-solving capabilities * Effectively collaborates with cross-functional team members * Exceptional organizational skills with the ability to multi-task and prioritize * Attention to detail * Ability to work with distributed team members and outside vendors Preferred: * Experience in scientific discipline and multiple therapeutic areas

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