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