Senior Consultant – Global Clinical Supply Chain Operations
Salary: £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:
1. Investigational material activities for global Trial Phases I-IV, including coordination of packaging, labeling, and distribution.
2. Collaborate with medical, regulatory, and clinical experts to ensure that quality Clinical Supplies are provided.
3. Interact with internal and external supply chain and logistics personnel in the procurement of clinical drug supplies.
4. Technical assessment and selection of contract packaging vendors; review and approve contracts for packaging and labeling activities and monitor budget.
5. Coordinate QP release of investigational materials to be used in the EU.
6. Review and approve IVRS specifications from investigational materials perspective.
7. Forecast and order bulk drugs from manufacturing vendors and other suppliers.
8. Responsible for development of clinical supply plan and packaging design.
9. Co-ordinate the design of clinical labels to meet protocol, FDA, EU and country specific requirements.
10. Write/review the Study Medication Sections of the protocol and IND as required.
11. Monitor Investigational Materials inventories and expiry/retest dates supplies.
Profile Requirements:
1. BSc Degree or related scientific discipline.
2. Min 6+ years pharmaceutical industry experience in global clinical supplies.
3. Extensive experience in the management of multiple studies globally.
4. Investigational material activities for global trials.
5. Comprehensive operational experience in R&D Clinical Supplies and related areas.
6. Expert in project management, packaging, labeling and distribution to clinical studies on a global level.
7. Excellent knowledge of GMP (current Good Manufacturing Practices for Finished Pharmaceuticals) and EU/country specific regulations regarding clinical studies.
8. Thorough understanding of the development and clinical supplies process.
9. 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.
Job Info
Job Title: Senior Consultant – Global Clinical Supply Chain Operations
Company: CV-Library
Location: Watford, Hertfordshire
Posted:
Closes: Jan 11th 2025
Sector: Medical, Pharmaceutical & Scientific
Contract: Contract
Hours: Full Time
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