The TMF Specialist acts as Subject Matter Expert (SME) and ensures accurate set-up, maintenance and archiving of the Trial Master File (TMF). The TMF Specialist initiates relevant plans and tools, keeps oversight on the content and supports quality reviews of the TMF, ensuring continuous audit/inspection readiness.
Set-up and maintenance of TMF:
Set-up and maintain the TMF for assigned studies:
- Set-up new studies in eTMF and in the pre-archive room
- Create, with input of the Clinical Study Team (CST) members, the study specific TMF plan and index worksheet; update the plans when needed throughout the study
- Maintain study specific Expected Document Lists (EDLs) at study and country levels by collaborating with all relevant stakeholders (e.g. Data Management, Clinical, Regulatory, etc)
- Ensure placeholders are correctly and accurately in place for the study
- Support CST-members in the management of study documentation (including uploading documents in eTMF, scanning, managing paper originals) ensuring a complete, contemporaneous, quality and audit/inspection ready TMF
Support CST-members and other relevant TMF stakeholders in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the CST
- Conduct appropriate Quality Reviews (incl. final quality review) on TMF documents
- Upon request, support CST members with Quality Review (incl. final quality review) of vendor TMF documents
- Provide reports and metrics on completeness and quality of TMF documentation and content to CSL on regular basis; take the appropriate relevant actions to address gaps, issues and risks
- Support CST-members to ensure audit/inspection readiness of allocated stud(y)/(ies) at all time
- Escalate any issues regarding TMF content, quality and follow-up to CSL, TMF owner and flag major variances to functional line management; support the CST in TMF document retrieval during Audits and Inspections (paper and electronic)
- As applicable, interact with the Quality Management Lead and follow-up on audit reports
- Ensure a timely creation of a CAPA-plan and timely CAPA closure
- Ensure proper archiving of TMF components from all relevant stakeholders; ensure smooth transfer of vendor TMF components into eTMF and proper archiving of the full TMF
- Perform inventory activities and quality review if deemed necessary for on and off-site storage records of legacy studies, as appropriate
- Internal primary point of contact for TMF related activities for assigned clinical stud(y)/(ies), working in close interaction with CST members
- Graduate or Degree in administration, office management or scientific degree
- Minimum 2 years clinical research experience with relevant exposure to and 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
- Experience/knowledge of ICH/GCP E6(R2) guidelines on documentation requirements
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
- Have at least intermediate 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
- 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.
Evelien Van Eecke