Global Clinical Project Manager
A contract opportunity has become available for a Global Clinical Project Manager in London. This is an exciting chance to join a large biotech and 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.
- Under supervision, may participate in or lead departmental strategic initiatives.
- Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
- Participate in CRO calls as necessary.
- Conducts Monitoring/co-monitoring as required.
- Contributes to Clinical Operations International team activities & initiatives.
- May serve as a resource for others within the company for clinical trials management expertise.
- Under general supervision, is able to examine functional issues from an organisational perspective.
Skills and Requirements
- University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
- Relevant pharmaceutical industry and/or clinical trial experience.
- Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
- Proven organisational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
- Demonstrated ability to work well both on a cross-functional team and independently
- Strong collaborative communication skills (verbal & written) in English
- Ability to prioritise appropriately and to be adaptable
- Demonstrated leadership skills
- Computer proficiency in day-to-day tasks
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.