Senior Manager global Clinical Supply Chain Operations - fully remote working
GBP90 per hour (experience dependent) + min 12-month contract with excellent possibility of permanent opportunity thereafter + immediate start available + 100% remote working + collaborative global team environment
Senior Manager global Clinical Supply Chain Operations 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 or related scientific discipline.
- Min 6+ years pharmaceutical industry experience in global clinical supplies.
- Extensive experience in the management of multiple studies globally.
- Comprehensive operational experience in R&D Clinical Supplies and related areas.
- Highly experienced in investigational material activities for global trial phases I-IV, including coordination of 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 projects around the world. If you are available at relatively short notice, then please send your profile and one of our team will be in touch.