Hobson Prior are currently working with a large pharmaceutical company who are determined to deliver pioneering medicines to enable better health for patients around the world. Our client is looking for a eTMF Specialist to join them on a 6 month contract basis with the probability of extension.
- Complete an ongoing quality control of the eTMF and ensure its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
- Raise 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.
- Deliver 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.
- Complete review of the eTMF management plans and provide relevant input.
- Arrange secure shipments of wet-ink documents.
- Deliver support by eTMF related audit or inspections.
- IT literate, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File.
- Fluent knowledge of spoken and written English is required.
- Ability to work on multiple studies simultaneously.
- Capability to work within a team in a matrix organization.
- Excellent problem-solving 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.
- In-depth 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.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.