Company: Planet Pharma Staffing Limited
Closing Date: 25 Dec 16
Salary (£): 60,000 - 80,000
Benefits: No benefits
Are you looking to join a Pharmaceutical company that can make a difference? Do you have strong managerial experience? Are you looking for your next assignment?
Project Management of Investigational Medicinal Product (IMP) supply for assigned clinical trials, implementing strategy defined in collaboration with stakeholders, and providing visibility on clinical supply chain throughout trial:
Plan, coordinate and communicate clinical supply activities for all applicable clinical trials to optimal quality, time and budget.
Manage the complete IMP supply chain for assigned studies.
Scope: All clinical trials (phase 1-4) + Expanded Access Programs with CTS involvement
- Manage the set-up, maintenance, and close-out of assigned multi-national Phase 1-4 trials (through delegation to Clinical Supply Associates when deemed appropriate):
- Drive strong partnership with stakeholders, in particular Clinical team. Participate in Joint Clinical Study Teams as a liaison for CTS. Educate and influence as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain.
- With guidance of Clinical Supply Program Manager, define an optimal IMP supply strategy to ensure adequate and sufficient forecasting of drug product, comparators, and final IMP.
- Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical sites.
- Set-up and write Core Label Text documents and coordinate the Country Label Text translation and regulatory approval process.
- Achieve planned milestones regarding clinical supply related trial set-up activities including packaging, labeling, Interactive Response Technology (IRT) requirements/specification development, distribution, and return/destruction.
- Contribute to IRT specification development by defining the requirements for IMP/inventory management. Participate in IRT User Acceptance Testing.
- Lead/Contribute to Operational Kick-Off Meetings with CTS functions, Distribution and QA, to share study information, collect input on packaging design and timelines, and agree on the trial project plan.
- Monitor IMP inventory quantities and expiry dates.
- Present IMP information at Investigator Meetings.
- Plan and monitor CTS trial budget, and communicate any required adjustments to Clinical team and Clinical Supply Program Managers.
- Ensure Clinical Supply Program Manager visibility on clinical supply chain for assigned trials, proactively identifying risks and escalating issues.
- Suggest/contribute to/ lead CTS process improvement initiatives
- Manage deviations, investigations and change controls in the Quality Management System (Trackwise)
- Lead/Participate in the writing and review of procedure, instructions and forms. Train CTS colleagues on these procedures and instructions.
- Implementation of project management best practices
- Partnership with Key Stakeholders, Drive Early/Formal Involvement
- End-to-End Optimization, Successful Patient Supply
- Patient Value Creation
Bachelor degree in sciences and a minimum of 2 years of CTS-relevant experience. Master’s degree preferred.
- Knowledge of GxPs
- Project management
- Supply chain management
- Active collaboration
- Coordination skills
- Proactivity & Risk management
- Agility, change management
- Problem solving: Address areas for improvement, propose creative solutions, and support the development and implementation of improvements.
- Communication & Presentation skills (English fluency). Internal contacts with: CTS Functions, Global Distribution & Logistics, Global Clinical Sciences & Operations, Exploratory Project Management, CTS/Clinical Quality Assurance, Regulatory Affairs, Biostatistics, Finance. External contacts with: Contract Research Organizations, IRT Vendors, Clinical Sites.
Sam Chapple at Planet Pharma is handling this vacancy. Please call his direct dial or email any questions.
DD: +44 203 868 8607
10 Greycoat Place, London,
|Tel:||+44 203 868 1000|
|Website:||Visit Our Web Site|
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