TMF Study Owner

Working for Phlexglobal you will be working in collaboration with one of Phlex’s top 10 blue-chip clients as a TMF Expert. The role can be office based in Chesham, Buckinghamshire or home based within the UK. This position is a permanent position.

You will be an ambassador of the TMF. Working with global client’s or CRO study teams, you will possess strong communication skills with the ability to lead and coach the study teams in good TMF practices ensuring the TMFs are Inspection ready at all times. As part of your role, you will setup a TMF structure to facilitate study teams to file and have oversight of TMF metrics. You will be a core team member attending regular study team meetings, managing the compliance and health of the TMF by advising the Project Managers and Study team of compliance issues and following up until resolution.

We are looking for individuals who have:

  • Previous direct TMF working experience.
  • Extensive Clinical Documentation Management and industry experience, with a thorough understanding of clinical trial project lifecycle and document management.
  • Experience with Electronic document management systems and other Clinical Databases.
  • Experience supporting regulatory submissions and inspections.
  • Intermediate MS Word, Excel, PowerPoint and Outlook. Experience of using Skype and other web based telephone conference services
  • Excellent negotiation and conflict resolution skills. Communicating well with colleagues and associates both inside and outside the organization.
  • Able to work independently, be proactive, diligent and self-motivated.
  • Have a flexible approach (sometimes outside of normal UK working hours) in order to be able to support teams worldwide.
  • Extensive knowledge of vendor processes.
  • A sound knowledge of working across international boundaries and cultures.
  • Flexibility to travel national/internationally (as and when required.)

The ideal candidate will have:

  • A Bachelor’s degree
  • Previous remote working experience

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