Senior Consultant – global Clinical Supply Chain Operations

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