Global Clinical Project Manager

£60000 - £65000 per annum
  1. Contract
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
London, England
Posting date: 25 Mar 2021

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.