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Catalent Pharma Solutions
,
Nottingham, Nottinghamshire
Clinical Supply Manager
Overview
Job Description
Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Catalent Pharma Solutions are looking to recruit a Clinical Supplies Manager (CSM) to join our team based supporting our Clinical Supplies network.. The Clinical Supplies Manager (CSM) under the guidance of the Senior Clinical Supply Managers/Regional Manager undertakes the activities required to lead and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The Role * Understand and translate clinical study protocol requirements into demand for drug product within a clinical study * Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs * Creation of initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies * Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug * Create a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug * Works with IRT in creation of system specifications (URS) associated with supply algorithms * Will update clinical demand forecast workbooks (excel and Optimiser). * Act as Un-blinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study * Monitor and oversee Warehouse and Depot drug levels within IRT throughout study. * Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable * Will be the Client Advocate for work on the assigned project. * Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study * Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life The Candidate * Bachelor's degree in a science, supply chain or related discipline * 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 and 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 * Excellent interpersonal skills and problem solving/decision making skills * Experience of using MS Office programs, with a particular aptitude for MS project and Excel. * Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management Our 7 standard leadership competencies * Leads with Integrity and Respect * Delivers Results * Demonstrates Business Acumen * Fosters Collaboration and Teamwork * Champions Change * Engages and Inspires * Coaches and Develops Position Benefits * Annual Salary * Pension * Bonus * Life Assurance * Bupa Healthcare Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified app