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Manager, Trial Supplies Management
Bristol Myers Squibb
Moreton, GBR
Full-time
Mid · 2+ years experience
Hybrid
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IVRSCTMS
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Role Overview
Executes supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
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IVRSCTMS
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Position Summary
Executes supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
Roles and Responsibilities
- Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met.
- Partners with the Clinical Supply Lead (CSL) in planning and communicating the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals. Demonstrates strong knowledge of GCSC processes when presenting at cross-functional meetings.
- Contributes to strategies for continuous improvement, both departmental and/or inter-departmental.
- Influences clinical and development timelines, study design and country selection. Responsible for reviewing and working with the CSL to provide any contributions to the clinical protocol and directly responsible for protocol amendments, communicating timelines and investigational product strategies to study and cross-functional teams
- Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
- Issues Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
- Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
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