Hobson Prior currently have an opportunity for an ETMF Specialist to join a leading patient-focused pharmaceutical organisation in Switzerland. Our client is focused on offering life-changing treatments to enable people all over the world to live a healthier and brighter future.

Job Responsibilities:

• Perform an ongoing quality control of the eTMF, ensuring 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 support by eTMF related audit or inspections.
• Offer 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.

Key Skills:

• 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.

Requirements:

• 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.
• Minimum 5 years of clinical trial experience in the pharmaceutical industry or university hospital, with a minimum of 3 years' experience with the eTMF.

Apply now:

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.