eTMF specialist wanted for our Zurich based client within the Pharmaceutical sector.
Your experience / skills :
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.
Your tasks :
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.
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
Contribute to the revisions of the eTMF process and system enhancements.
Perform review of the eTMF management plans and provide relevant input.
Provide support by eTMF related audit or inspections.
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-
permit holders for Switzerland.
Going the extra mile
New to Switzerland? In case of successful placement, we support you with :
All administrative questions
Finding an apartment
Health and social insurance
Work permit and much more