Beschreibung
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.
Start: ASAP
Duration: 6 MM
Location: Zurich, Switzerland
Ref.Nr.: BH 14642
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