Job Description

Senior Consultant – global Clinical Supply Chain Operations

£80-90 per hour (experience dependent) + min 12-month contract + immediate start available + 100% remote working (3-4 trips a year to HQ as required) + collaborative global team environment + opportunity for a permanent role in the future, if of interest.

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 Consultant – global Clinical Supply Chain Operations profile:

* BSc Degree or related scientific discipline.

* Min 6+ years pharmaceutical industry experience in global clinical supplies.

* Extensive experience in the management of multiple studies globally.

* Investigational material activities for global trials.

* Comprehensive operational experience in R&D Clinical Supplies and related areas.

* Expert in project management, packaging, labeling and distribution to clinical studies on a global level.

* 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 trial projects globally. If this is of interest & you have the experience required, then please send your profile and one of our team will be in touch soon