Clinical Supply Manager Contract

6 Month Contract

£42 Umbrella

Commutable from: Remote working Office in Bathgate

UK and overseas (COVID permitting) travel

Your Profile

As a Clinical Supply Manager (Pharmaceutical), you should have experience in performing the activities required to provide leadership 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 Clinical Supplies Project Manager is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.

The Role

Clinical Supply Manager (Pharmaceutical) will consult with client, CRO, Packager, Logistics and IRT as necessary to lead or assist the following as required:

• 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
• Create 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 re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
• Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
• Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
• Works with IRT in creation of system specifications (URS) associated with supply algorithms
• Act as Unblinded 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.
• Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
• Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study
• Assist in the provision of budget estimates in support of quotations for clients
• Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
• May provide support of training of other Project Managers in aspects of clinical supply management
• May provide input in development / improvement of existing business processes and contribute to the revision or development of associated training materials
• May participate in Business Development activities to grow the business

Knowledge/Skills Requirements:

·         Bachelor’s degree in a science, supply chain or related discipline

·         Minimum of 6+ years of relevant industry experience with experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle

·         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),

·         Working knowledge of global supply labeling requirements

·         Extensive experience of using MS Office programs, with an aptitude for MS project and Excel.

·         Strong knowledge in IRT technology as it relates to supply chain management

The Company

In return you will be part of an extremely successful organisation within the pharmaceutical industry.