TMF Owner

Job description

As a TMF Owner, you will be TMF Subject Matter Expert and advisor for the Clinical Study Teams on (e)TMF set-up, management, close-out and quality control to ensure a complete and accurate TMF. Implement consistency across clinical studies and programs. Provide crucial TMF quality support to and establish a proactive quality-focused partner-relationship with the Clinical Study Teams.

  • Act as TMF subject matter expert and super user for eTMF tool; manage & maintain training for new comers and refresher training to existing users. 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 and TMF specialists on all aspects of the TMF projects.
  • Provide input on the revision of TMF related Work Instructions, Guidelines, Forms (e.g. TMF plan, oversight/QC tracking tools) and SOP. Provide advice on the implementation of TMF procedures and standards
  • Support Clinical Study Assistants (CSA) and Leaders (CSL) in the set-up and maintenance of an eTMF for assigned studies; oversee Clinical Study start-up, conduct and close-out including impact assessment of potential changes
  • Provide guidance, clarification and strategy for regulatory requirements and compliance
  • Guide the study teams in the creation and maintenance of the study specific TMF plan
  • Ensure – in cooperation with ITS – smooth transfer of vendor TMF components following Data import processes for electronic components.
  • Set-up agreements with vendors (on governance level) on TMF processes and transfers
  • Support multifunctional Clinical Study Team(s) and/or related stakeholders in resolving issues identified during TMF management, including during electronic document uploads into internal systems (eTMF/eDMS)
  • Coordinate TMF related Inspection Readiness initiatives.
  • Provide input and advice to audit report responses
  • Provide reports and metrics on completeness and quality of TMF documentation and content to Head Clinical Operations on regular basis; monitor timelines and document quality standards; take the appropriate relevant actions to address gaps, issues and risks; Analysis of error trends to promote continuous improvement, providing input to CSAs/ TMF specialist..
  • Maintain a global tracking of TMF locations during study and upon archiving, e.g. company’s TMF, vendor TMFs
  • Oversee the archiving activities of TMF components from all relevant stakeholders
  • Coordinate inventory activities for off-site storage records (old studies), as appropriate
  • Participate in/present at departmental meetings
  • Actively initiate and participate in Process Improvement initiatives
  • Minimum Master in life sciences or equivalent by experience
  • Good understanding of drug development as well as a solid experience in clinical study management is highly recommended.
  • Experience in TMF management, knowledge of TMF Reference Model, ALCOA+ standard, Good Documentation Practices or relevant working experience in pharmaceutical/scientific environment: i.e. thorough understanding of the processes associated with the conduct of clinical studies and document management operations.
  • Exposure to process improvement initiatives and creation of SOPs, guidelines and templates is highly recommended
  • Experience working in a matrix managed environment and ability to adapt to corporate culture.
  • Excellent knowledge of ICH/GCP E6(R2) guidelines and other applicable regulations.
  • Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
  • Have high level Microsoft Office (Excel, PowerPoint, Word, Outlook, Excel) knowledge
  • 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
  • Good leadership and presentation skills
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
South of Antwerp
Contact person

Rafael Hoebrechts

Personal profile
Contact details
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46