For one of our clients we are looking for a eTMF Specialist.
- Are you fluent in English (written and spoken) ?
- Do you have excellent problem solving skills ?
- Do you have a comprehensive practical knowledge of TMF processes ?
Then you might be the candidate we are looking for! Don't hesitate to apply now!
Support the development delivery functions with tasks related to the eTMF quality control and maintenance. Provide guidance on the eTMF process and practical support on how to use the system. Follow up with the internal and vendor functions on the eTMF quality issues until their resolution.
- Perform an ongoing quality control of the eTMF. Ensure its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
- Escalate to the relevant functions any limiting factors and non-compliance related to the eTMF quality and provide comprehensive guidance on issue resolution.
- Monitor the eTMF quality issues and follow up with the relevant functions (sponsor / vendor) until their resolution.
- Provide regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan. Provide practical support to eTMF users on the use of the system.
- Contribute to the revisions of the eTMF process and system enhancements.
- Perform review of the eTMF management plans and provide relevant input.
- Arrange secure shipments of wet-ink documents.
- Provide support by eTMF related audit or inspections.
- Bachelor degree or equivalent, preferably in life science, clinical re- search, or related discipline.
- Comprehensive practical knowledge of TMF processes, related standards (e.g. DIA Reference Model) and its quality control.
- Thorough understanding of ICH-GCP quality standards and other relevant regulations
- Minimum 5 years of clinical trial experience in the pharmaceutical industry or university hospital, with a minimum of 3 years’ experience with the eTMF.
- IT literacy, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File.
- Fluent knowledge of spoken and written English.
- Ability to work on multiple studies simultaneously.
- Very good self-organization, time management skills, independent and structured way of working.
- Ability to work within a team in a matrix organization.
- Excellent problem solving skills.
+32 15 21 11 04
Project for 1 year.