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
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