Description
We are looking for a
eTMF Specialist (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Zurich region
Branch: Herstellung von pharmazeutischen Erzeugnissen
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
- 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
Your qualifications
- 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
- Profound experience in the field of clinical trial in the pharmaceutical industry or university hospital, as well as solid experience with the eTMF
- IT literacy, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File
- Fluency in English (spoken and written)
- 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
Skills:
- Clinical trial assistant