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 environmentDemonstrated ability to work well both on a cross-functional team and independentlyStrong collaborative communication skills (verbal & written) in EnglishAbility to prioritise appropriately and to be adaptableDemonstrated leadership skillsComputer 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.#LI-_MP1