Lead Trial Master File Study Owner

Love TMFs but tired of Filing? Do you have a passion for travel and have what it takes to be a Lead TMF Specialist? We have this exciting role for you if you do!

Working for Phlexglobal you will be working in collaboration with a dynamic fast growing Biotech company based in Belgium. You can be home based in the UK but you will be expected to work from our clients office in Belgium two days per week. This position is a fixed term contract for 12 months.

As a Lead TMF Study Owner you will be the point of contact for the Clinical Study Leaders, Clinical Study Teams and other TMF stakeholders to ensure a complete and accurate TMF through documentation quality and consistency across clinical studies and programs. You will provide crucial TMF quality support and establish a proactive quality-focused partner-relationship with the Clinical Study Team.

Key Responsibilities:

  • Act as subject matter expert for TMFs and systems. Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes
  • Communicate to the Clinical Study Assistants (CSA) on all aspects of the TMF projects
  • Provide guidance, clarification and strategy for regulatory requirements and compliance
  • Provide advice on the implementation of TMF procedures and standards
  • Contribute to the development of TMF processes based on the input from Client Management, Clinical Study Leaders (CSL) and Functional Area Teams
  • Oversee Clinical Study Start-up, Clinical Study Conduct and Clinical Study Closeout including impact assessment of potential changes
  • Provide input and advice to audit reports responses
  • Conduct an analysis of error trends to promote continuous improvement, providing input to CSAs
  • Monitor timelines and document quality standards, including the identification of trends regarding potential issues and obstacles, providing feedback to CSAs

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 (Veeva experience preferred).
  • Experience supporting regulatory submissions and inspections.
  • Intermediate MS Word, Excel, PowerPoint and Outlook. Experience of using Skype and other web based telephone conference services
  • Extensive knowledge of vendor processes.
  • Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
  • Ability to remain calm/focused in high-stress situations and maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
  • Be flexible, pro-active, self-motivated and able to work independently with minimal supervision. Be able to prioritize and seek input where necessary
  • Good verbal and written communication skills
  • Have a flexible approach (sometimes outside of normal UK working hours)
  • A sound knowledge of working across international boundaries and cultures.
  • Ability to travel to Belgium 2 days per week

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