Contract Global Clinical Project Manager
Proclinical have a unique chance for a Clinical Project Manager to join one of the leading pharmaceutical companies in London. You will be expected to provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
- Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
- Contributes to development and maintenance of study budgets.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Manages CROs/vendors for assigned post-authorisation studies.
- Communicates project status and issues and ensure project team goals are met.
- Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
- Maintains study timelines and communicates adjustments where necessary.
- Develops good working relationships with Gilead US late phase operational team and cross-functional staff internationally as required.
- May participate in the preparation of interim/final clinical study reports.
- May contribute to development of abstracts, presentations, and manuscripts.
- Keep study status in Clinical Trial Management System up to date for assigned studies.
- Contributes to Clinical Operations International team activities & initiatives.
- Works with Clinical Program Managers to manage the regional component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
- Interacts with cross-functional teams internally and externally to ensure study progress
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Skills and Requirements
- BSc, MSc or PhD qualification
- 2+ years Global Clinical Project Management experience required
- CRA background (desired)
- Global experience
- Phase I-III
- Bid defence experience
- Strong budget management experience
- Able to manage the monitoring activities of CRAs
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.