Clinical Study Manager
A global pharmaceutical company based in London is offering a 12-month rolling contract for a talented Clinical Study Manager. This is an exciting chance to come into a company and help drive forward their study.
- 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.
- Keep study status in Clinical Trial Management System up to date for assigned studies.
- May serve as a resource for others within the company for clinical trials management expertise.
- Under general supervision, can examine functional issues from an organizational perspective.
Skills and Requirements
- Must have a degree BS in science related field
- Must have multinational (preferably EU) clinical trials experience including study management/coordination.
- Monitoring experience highly desirable as site oversight monitoring visits will be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to generally understand, interpret, and explain protocol requirements to
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com/send-cv