Trial Supplies Manager
CK Group are recruiting for a Clinical Trials Supplies Manager to join a Biopharmaceutical company on a full time basis for an initial 12 month period. To start with the role can be carried out remotely, however they would expect the successful candidate to attend the offices in Stockley Park when this is allowed and possible.
Company: This company is a successful global biopharmaceutical company that discovers and develops innovative medicines and solutions for people living with severe diseases of the immune or central nervous systems. The company works across approximately 40 countries across Europe and the rest of the world.
The Role: The main purpose of the role will be to:
- Collaborate with internal and external Customers andService Providers, within Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
- Work with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.
- Co-create clinical and development timelines and be directly responsible forcommunicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
- Proactively define, plan, and communicate clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
- Develop supply forecasts through evaluation of the clinical development plan and protocol analysis.
- Review and provide input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners.
- Collaborate with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements.
- Monitor long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
- Perform analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.
- Work with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities.
- Ensure releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements.
- Initiate, review and approve IRT specifications. Participate inuser acceptance testing.
- Develop investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements.
- Actively participate in Trial Supplies ManagementFunctional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
- Act as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate.
Your Background: To succeed in this role, you will come from a life sciences or pharma background, with a proven experience in trial supplies management:
- Knowledge of the global drug development process and global regulatory requirements.
- Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
- Proficient knowledge of import / export requirements.
- Proficient/Strong knowledge of IRT and CTMS systems.
- Applies and drives Forecasting and Planning activity as it relates to protocol.
- Ability to build/drive internal team consensus.
- Translates broad strategies into specific objectives and action plans.
Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Steve Lord on 01246 457 738 or email firstname.lastname@example.org. Please quote reference 49544 in all correspondence.