eTMF Specialist

eTMF Specialist

Experis IT Switzerland is currently on the search for a eTMF Specialist 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.

Project Details:

• 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

Your profile:

• 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.
• Ability to work on multiple studies simultaneously
• Good self-organization, time management skills, independent and structured way of working
• Ability to work within a team in a matrix organization
• Fluent in English

Location: Zürich
Duration: 6 months contract

Don't hesitate and send us your CV and testimonials today through the link in the advert.