Jim Gleeson is recruiting for a Senior Manager, Clinical Outsourcing to join well established, global pharmaceutical company. The role can be home based with occasional trips to their Hertfordshire offices for necessary meetings.
As Senior Manager, Clinical Outsourcing you will negotiate, implement and administer the service and/or financial terms of contracts with Contract Research Organizations (CROs) and R&D contract vendors such as research organizations and commercial central laboratories.
Key duties will include:
- Supporting the development of outsourcing requirements for Phase I-IV global clinical trials including functional services.
- Leading and supporting the qualification and evaluation process for new service providers.
- Managing the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
- Facilitating study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets.
- Managing assigned service provider relationships ensuring successful start-up and efficient outcomes, as applicable.
- Collaborating effectively with all relevant functional departments (e.g., Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
- Maintaining a central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary.
As Senior Manager, Clinical Outsourcing you will require:
- Demonstrated experience in managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
- Demonstrated business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g., IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO).
- Excellent written and oral communication skills
- Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others.
- Good leadership and project management skills
- Thorough knowledge of GCP/ICH Guideline and Regulations
Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email email@example.com. Please quote reference 52714 in all correspondence.