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Clinical Supply Manager

Clinical Supply Manager

Job Title: Clinical Supply Manager
Contract Type: Permanent
Location: Worthing
Industry:
Salary: £TBD on application plus benefits including bonus
Start Date: 2020-09-22
Reference: V-46387
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: September 23, 2020 09:50

Job Description

My client is a pioneering immunology company leading the market in allergy vaccines. They have developed an innovative approach to medical treatments over several decades and are in an exciting phase of expansion across Europe and the USA. The company has an excellent reputation for its welcoming atmosphere, staff morale and ongoing career development. 

Overview:
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

Responsibilities:
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.

Study Execution 
• 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

Qualifications/Experience required:
• 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.

Location:
Flexible working offered.