Clinical Trials Manager.

Greater London/ contract /

The CTM role will involve regional management on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region. The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. The candidate will likely work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. The successful candidate will have the ability to work successfully with cross-functional team members globally and to manage stakeholders accordingly. Specific Responsibilities
  • Works with Clinical Program Managers to manage regional component of Virology clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
  • Interacts with cross-functional teams internally and externally to ensure trial progress
  • Incorporate study logistics and planning to accomplish study objectives
  • Serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems
Knowledge, Experience and Skills

  • Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline
  • Previous experience in Virology areas would be advantageous but not essential
  • Previous study management/coordination experience at Sr CTMA level
  • Monitoring experience is highly desirable as co-monitoring 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 have a general, functional expertise to support SOP development and implementation
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
  • Excellent teamwork, decision-making and organizational skills are key to success
  • Strong communication skills