Clinical Supply Manager
|Job Title:||Clinical Supply Manager|
|Salary:||£TBD on application plus benefits including bonus|
|Contact Name:||Alex Butcher|
|Job Published:||September 23, 2020 09:50|
To design, plan and execute all matters related to the supply of investigational product, companion diagnostics and ancillary supplies to meet the requirements of the patients, investigators and business objectives
Clinical Supply (80%)
• Act as the primary point of contact for all matters related to the supply of clinical trial material
• Translate the clinical trial protocol or study plan into a comprehensive clinical supply strategy
• Forecasting the amount of clinical trial material required
• Developing a pharmacy manual to support investigational teams at study sites to prepare accurate doses
• Collaborating in building the RTSM
• Lead clinical trial supply vendor selection process from request for information to award
• Liaise with the Early Phase Project Manager to ensure supply chain logistics are consistent with requirements for transfer of materials, e.g. requirements for cold chain, product shelf-life and interpretation of study protocols.
• Execute all project specific activities related to IMP, NIMP and Ancillary (and other supply chain items as required)
• Liaise with Head of QA to identify and resolve any quality related issues in clinical supply chain
• Provide strategic input for future projects in terms of improvement in Clinical Supply Chain management
Systems and change management (20%)
• Provide user-friendly stock inventory management forecasting tool based upon R&D roadmap. Ensure logistical issues in planning forecast and acceptance of stock from manufacturing operations.
• Ensure all change triggered by stock request is considered as justification for change control
• Relevant experience of clinical supply chain management
• Pharmacist background is preferred
• Experience of vendor/ contractor management and collaboration.
• Knowledge of complexity in clinical supply chain logistics
• Understanding ICH, EMEA, MHRA and FDA guidance documents, regulatory documents and QMS in a clinical setting.
Flexible working offered.
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