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Search for Jobs by Sheryl Horowitz

Clinical Supply Manager (Science & Biotech)
Durham, NC 27703
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Aug 20, 2021
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Job Description

Our client, a global pharmaceutical company and a terrific team, is currently hiring!

Overall Purpose:
The Clinical Supply Manager is responsible for the successful execution of supply chain activities for multiple clinical trials both domestically and internationally. This role is to provide guidance and oversight of all clinical supply chain operations. Working collaboratively across multiple functions internally and externally, this individual is accountable for ensuring clinical supply needs are met to start and complete studies as defined without supply interruption. The Clinical Supply Manager is task with Label and Packaging vendor selection, the development of timelines to meet clinical needs, and leading the execution of the supply timelines within the budget.

Duties & Responsibilities:
• Provide Oversight for operations related to clinical packaging, labeling, distribution and returns
• Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment
• Collaborate with Clinical Operations, Quality, Product Development, Regulatory Affairs, and Clinical Packaging and Distribution Contract Research Operations (CRO’s) to ensure Clinical material is available as required
• Support clinical trial strategy in the US and Globally to meet timelines across projects / products
• Develop, manage, and utilize appropriate inventory reporting tool(s) for maintaining clinical supply inventory and forecast records
• Label text development, label specification review and approval, packaging and labeling operations including design of clinical supply kits
• Manage communication and review process for recommended clinical packaging plans
• Communicate clinical packaging plans to applicable contract packaging sites, and ensure effective management of clinical packaging site activities including management of clinical site returns
• Lead label and packaging vendor selection activities to ensure service and cost meets the needs of the clinical programs
• Continuously track progress towards objectives and advise management of any issues impacting project timelines and provide solutions to the problems (SME)
• Develop and maintain information and reporting, in collaboration with Quality to ensure transparency of project / product current expiry periods, and plans for expiry extension
• Collaborate with Clinical Trial Managers to develop the drug distribution strategy for each trial and lead the development, review, and acceptance testing of IRT or equivalent when applicable
• Monitor and report on clinical supply inventory for each project / product
• Manage and track inventory at site level and place manual orders as needed

• Other duties and activities as defined by management to enhance management of clinical trial inventory
• Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements
• Collaborate with Supply Chain Planning to ensure that clinical supply inventory and forecast information is included in the integrated planning process
• Collaborate with CRO’s to track and manage invoices

Key skills/desired experience:
• Ability to communicate effectively both orally and in writing
• Ability to work both independently, and in a fast-paced dynamic team environment
• Experience with logistics and distribution in cGMP environment.
• Experience with Cold Chain
• Solid understanding of relevant FDA and EU regulations
• Strong analytical and organizational skills

Education and Experience Qualifications:
Bachelor’s degree in an applicable discipline with 10 - 12 years clinical supply management or equivalent experience in the pharmaceutical / biopharmaceutical industry (including Global Logistics, Packaging and Labeling)