Global Clinical Trial Supply Manager
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Hobson Prior are looking for a Global Trial Supply Manager to join a biopharmaceutical organization on a contract basis located in London. Our Client is focused on the discovery, development, and delivery of innovative medicines that will help patients overcome serious diseases and improve their quality of life..
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will Collaborate with internal and external teams including Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors, and Medical.
- Ensure optimal use of clinical supply chains by developing, planning, and communicating the strategy.
- Communicate GCSC processes clearly at cross-functional meetings.
- Support departmental or cross-departmental continuous improvement initiatives.
- Contribute to the development of clinical protocols, communicate deadlines, and develop investigational product strategies.
- Forecast study supply based on protocol analysis and clinical development plans.
- Consider country requirements and logistical timelines when assessing drug utilization.
- Work closely with Clinical Development, Chemistry, Manufacturing and Controls (CMC) and CSO Packaging and Labeling in accordance with RDSC Master Planning timelines.
- Ensure protocol is followed for investigational drug products. Generate Use Date Extension (UDE) memos for depots and clinical sites, and provide feedback to Logistics.
- Deliver quality clinical supplies in compliance with country regulatory requirements and QP release specifications.
- Review and approve specifications for Interactive Response Technology.
- Maintain distribution and supply strategies at site and depot levels in accordance with study and IRT requirements.
- Actively participate in internal meetings related to Trial Supply Management, Clinical Supply Chain, Study Teams, and Clinical Supply Matrix Teams by highlighting any risks.
- Coordinate with Clinical Supply Strategic Sourcing team to obtain commercial drugs aligned to countries and clinical studies.
- Meet with vendors and create purchase requests.
- Review and update supply and demand estimates for assigned studies in Budget Tool.
- Communicate with the study team regarding global supply strategy for the assigned compound.
- Support the associated actions stemming from the change control process.
- Prepare eTMFs, CSR appendices, and batch listings to support inspection readiness.
- Help PDQ resolve product complaints and deviations.
- Interact with customers and partners to resolve conflicts.
- As needed, prepare departmental procedural documents.
- Ability to analyze problems effectively and efficiently.
- A strong ability to communicate and negotiate.
- Ability to manage projects effectively and efficiently.
- Expertise in Forecasting and Planning, as well as Packaging & Labeling, IVRS, Logistics, Quality, and Stability.
- An in-depth understanding of import and export regulations is required.
- Proficient or strong knowledge of IVRS/CTMS.
- A strong understanding of the technology used in the industry is required.
- Understanding and applying Forecasting and Planning activities in relation to protocol.
- Demonstrated ability to build consensus internally within the team.
- Ability to translate broad strategies into specific objectives.
- Capable of leading both as a team and as an individual (leads courageously).
- A good communicator, both orally and in writing
- Ability to manage disagreements and resolve conflicts.
- Good negotiation skills, ability to manage execution, result-driven, ability to analyze issues, be effective in speaking, ability to build relationships.
- The ability to coach and mentor (fostering teamwork).
- Experience in a pharmaceutical industry related role of at least 2 years.
- A minimum of one year of experience with Clinical Supplies and Development with global exposure or equivalent experience is required.
- Knowledge of the global drug development process as well as global regulatory requirements at a moderate or advanced level.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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