Job Description

Senior Manager global Clinical Supply Chain Operations

£90 per hour (experience dependent) + 12month rolling contract + January start + 100% remote working + collaborative global team environment

Key responsibilities include;

• Investigational material activities for global Trial Phases I-IV, including coordination of packaging, labeling, and distribution.
• Collaborate with medical, regulatory, and clinical experts to ensure that quality Clinical Supplies are provided.
• Interact with internal and external supply chain and logistics personnel in the procurement of clinical drug supplies.
• Technical assessment and selection of contract packaging vendors; review and approve contracts for packaging and labeling activities and monitor budget.
• Coordinate QP release of investigational materials to be used in the EU.
• Review and approve IVRS specifications from investigational materials perspective.
• Forecast and order bulk drugs from manufacturing vendors and other suppliers.
• Responsible for development of clinical supply plan and packaging design.
• Co-ordinate the design of clinical labels to meet protocol, FDA, EU and country specific requirements.
• Write /review the Study Medication Sections of the protocol and IND as required.
• Monitor Investigational Materials inventories and expiry/retest dates supplies.

Senior Manager global Clinical Supply Chain Operations profile:

• BSc Degree/ MSc or related scientific discipline.
• Min 8+ years global clinical supply chain operations experience within a senior management role.
• Extensive experience in the management of multiple studies globally.
• Comprehensive operational experience in R&D Clinical Supplies and related areas.
• Expert in project management and investigational material activities for global clinical trials including packaging, labeling and distribution.
• Excellent knowledge of GMP (current Good Manufacturing Practices for Finished Pharmaceuticals) and EU / country specific regulations regarding clinical studies.
• Thorough understanding of the development and clinical supplies process.
• Extensive Vendor management experience; excellent interpersonal & planning skills.

The above contract role is an opportunity to join a forward-thinking & fast-paced global pharmaceutical business, serving as a core member for clinical supply chain operations around the world.

If you are confident you have the experience & skills required and you are happy to start in a long-term contract role, then please send your profile and one of our team will be in touch soon