Role posted on: 9th November 2018
We have an opening for a Clinical Supplies Manager to join our Clinical Operations team in the UK. The role would suit someone who has demonstrated experience in 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 position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.
Role Description: Clinical Supplies Manager, Slough, UK
- 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 deliverables.
- Bachelor’s degree in a science, supply chain or related discipline
- 6+ years of relevant industry experience with at least 4 years 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),
- Working knowledge of global supply labeling requirements
- Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
- Strong knowledge in IRT technology as it relates to supply chain management
- Skilled in client relationship management and ability to influence customer demand
- Excellent interpersonal skills and problem solving/decision making skills
- Extensive experience of using MS Office programs, with a particular aptitude for MS project and Excel.
- Strong communication skills both written and verbal
We are looking for enthusiastic and ambitious people to join our growing team. If the prospect of joining a team of progressive consultants excites you, please get in touch today.
If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.