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.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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