CK Group is recruiting for a Global Clinical Supply Manager to work with our client who are a global healthcare provider to hospitals, clinics and homes. The role will be remote based but require up to 3 days a month travel to Germany. The contract will be for an initial period of 6 months.
This position will come offered with an hourly rate of up to £65.44 LTD.
As the world's number one drug development, delivery and supply partner with over 80 years of experience, our client has helped thousands of innovators by optimizing and manufacturing thousands of pharmaceutical, biologic, consumer health and beauty products by utilizing their superior and innovative drug delivery technologies to improve their value to patients and consumers.
The Clinical Supplies Manager 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 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 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.
- Work 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.
To be considered for the role, you should have the following key skills, knowledge and experience:
- Bachelor's degree in a science, supply chain or related discipline.
- Relevant industry experience including 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.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46542 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Jennifer Woolley
- Phone: 01438 743047
- Reference: 46542
- Posted: 13th September 2019
- Expires: 11th October 2019