Do you have experience in clinical trials and does TMF have no secrets for you ? Do the words accurate, pro-active and adaptable describe you well ? Then you may be the candidate our fast-growing biotech client is looking for.
TMF Subject Matter Expert (SME) and responsible for a complete and accurate TMF with high documentation quality, ensuring continuous audit/inspection readiness. Provide crucial TMF quality support to the Clinical Study Team (CST) members. Establish a proactive quality-focused partner-relationship with the CST-members.
The TMF Specialist acts as SME and ensures accurate set-up, maintenance and archiving of the 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 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 GLPG 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
- A balanced salary package based on your capabilities and experience.
- Fulltime or 80%
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17235