Experis IT Switzerland is currently on the search for a eTMF Associate to join one of their clients, a well renowned global company. For this temporary assignment based in the heart of Zürich, we are in search of an English-speaking candidate who is immediately in a short notice.
Support the development and other functions with tasks related to the electronic TMF (eTMF) quality control and maintenance. May follow up with functions on the eTMF quality issues until their resolution.
- Perform an ongoing technical quality control of the eTMF for documents uploaded by Development and other functions based on guidelines provided. Ensure quality control completion in the system.
- Escalate to the document owners or relevant functions any limiting factors and non-compliance related to the eTMF quality and may provide guidance on issue resolution.
- Monitor the eTMF quality control completeness and follow up with the document owners or relevant functions until their resolution.
- May arrange secure shipments of wet-ink documents.
- Basic practical knowledge of TMF processes and its quality control guidelines
- Basic understanding of ICH-GCP quality standards and good documentation practice
- IT literacy, proficiency with Microsoft Office applications; practical experience with the electronic Trial Master File is not essential
- Ability to work on multiple studies simultaneously
- Pre-university education or Bachelor degree
- Fluent knowledge of spoken and written English.
- Good self-organization, time management skills, independent and structured way of working.
- Problem solving skills
Duration: 6 months contract
Don't hesitate and send us your CV and testimonials today through the link in the advert.