Clinical Supplies Manager

3 weeks ago

West Lothian, United Kingdom Hyper Recruitment Solutions Ltd Full time

Are you a Clinical Supply Manager looking for the next step in your career? We have a fully remote opportunity available for the right person
We are currently looking for a Clinical Supplies Manager to join a global pharmaceutical company based in Scotland (the role will be remote working from home).
As the Senior Clinical Supplies Manager you will be responsible for providing leadership and support in the planning, development, and execution of clinical supply chain activities and have the ability to drive cross-functional deliverables and manage activitiesof supply partners and functions (e.g. packaging and distribution, depots, logistics).
The Clinical Supplies 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 asthey arise
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Supplies Manager will be varied however the key duties and responsibilities are as follows:
1. 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 decisions in support of the design of optimized, lean supply chains for individualstudies or programs.
2. Create initial study drug projections and supply plans 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 occurringduring the study (enrolment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans.
3. 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 optimize as required tomake efficient use of clinical supplies while avoiding stock outs at study sites.
4. 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 IRTthroughout study.
5. 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.
ROLE REQUIREMENTS:
1. Relevant degree in a scientific, supply chain related or similar discipline. In addition, you will demonstrate relevant industry experience with experience in clinical supply management and sound knowledge of the complete clinical supplies life cycle.
2. Experience in supply tracking requirements and systems. Global logistics experience / understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management.
3. A working knowledge and practical experience with International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), EMA GMP and GDP Guidelines and a solid understanding of Good ManufacturingPractices (GMP).
Key Words: Clinical Supply | Pharmaceutical | Supply Chain | Logistics

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