Commonwealth Sciences, Inc. · 1 week ago
Sr. Clinical Supply Chain Manager
Commonwealth Sciences, Inc. is seeking a Sr. Clinical Supply Chain Manager to oversee drug management for multiple concurrent clinical trials. The role involves improving processes, collaborating with CMC and QA, and managing vendor relationships to ensure efficient supply chain operations.
BiotechnologyLife ScienceOutsourcingRecruitingStaffing Agency
Responsibilities
Will oversee drug management for multiple concurrent clinical trials from first-in-human studies through to pivotal studies, requiring in-depth understanding of GMPs, project management, IRT, drug accountability and supply forecasting
Proactively identifies areas for improvements and recommends solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness
Work collaboratively with CMC and QA to ensure trial supplies are appropriately supported including shelf life, inventories, country approvals
Lead the clinical label text creation, translation, approval process and printing activities for global clinical trials
Experience managing and working with Contract Packaging Vendor for scheduling and delivery of secondary packaging, labeling, IRT integration, distribution and return drug management activities
Working with vendors and/or CROs to contribute to the development within the IRT system requirements, user acceptance testing, and drug supply management
Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management
Qualification
Required
BA/BS degree
5 + years of relevant experience in clinical supply chain management in the biopharmaceutical industry associated with complex global trials
Anticipates and proactively identifies, recommends creative solutions or escalates issues for project resolution
Must have experience working across functional areas within CMC and Clinical Ops
Preferred
Experience with Phase 2 support