Beschreibung
eTMF Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM++
Main 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 and 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
Main qualifications
- Bachelor's 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 clinical trial experience in the pharmaceutical industry or university hospital and in-depth experience with the eTMF
- IT literacy, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File
- Fluent knowledge of spoken and written English
- 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
Main advantages:
- Reputable company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Tina Maric
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