Job Title: Senior Clinical Supplies Manager
Company Name: Catalent
Location: Bathgate
Hours / Days Of Work: To be clarified
Job Type: Full-Time
Salary: To be defined
Job Description:
Understand and translate clinical study protocol requirements into demand for drug product and ancillary supplies within a clinical study. Use simulation tools and supply chain expertise to provide decision support for the design of optimized, lean supply chains for individual studies or programs. Create study drug projections and supply plans for clinical trial supply needs throughout the life of the study, including multiple drug campaigns and appropriate drug strategies. Work with IRT in the creation of system specifications (URS) associated with supply algorithms. Update clinical supply demand forecasts as new information becomes available (Excel and available forecasting tools). Act as the Un-blinded Study Drug Manager in testing of IRT system (UAT) and throughout the life of the study. Monitor and oversee Warehouse and Depot drug levels within IRT throughout the study. Coordinate with the client and packager to forecast, plan, and schedule packaging campaigns.
Experience And Qualifications:
Bachelor's degree in a science, supply chain, or related discipline. Extensive, proven relevant industry experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle. Experience in supply tracking requirements and systems. Experience in the use of forecasting tools. Global logistics experience/understanding related to supply chains, import/export, drug depots, comparator or co-therapy product sourcing, and project management. Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR). Strong knowledge in IRT technology as it relates to supply chain management. Experience of using MS Office programs, with a particular aptitude for MS Project and Excel.
Application Process:
Apply via the link below.
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