eTMF Specialist

Proclinical is advertising an exciting opportunity for an eTMF Specialist position at a leading global research-based pharmaceutical company. Joining their team in Switzerland, the eTMF will have the opportunity to work with this company that boasts specialisation in multiple therapy areas and a superb pipeline.

The eTMF Specialist will supper the development delivery functions with tasks related to the eTMF quality control and maintenance. They will also provide guidance on the eTMF process and practical support on how to use the system. Finally, they will follow up with the internal and vendor functions on the eTMF quality issues until their resolution.

Job Responsibilities:

• Performing on going quality control of the eTMF.
• Ensuring its inspection readiness, i.e., completeness and compliance with the relevant requirements from study start-up until archiving.
• Escalating any limiting factors to the relevant functions, along with any non-compliance related to the eTMF quality and providing comprehensive guidance on issue resolution.
• Monitoring the eTMF quality issues and following up with the relevant functions (sponsor/vendor) until their resolution.
• Monitoring the eTMF quality issues and following up with the relevant functions (sponsor/vendor) until their resolution.
• Providing regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan, along with providing practical support to eTMF users on the uses of the system.
• Contributing to the revisions of the eTMF process and system enhancements.
• Performing review of the eTMF management plans and providing relevant input.
• Arranging secure shipments of wet-ink documents.
• Providing support by eTMF related audits or inspections.

Skills and Requirements:

• A bachelor's degree or equivalent, preferably in a life science, clinical research, or related discipline.
• A minimum of 5 years of clinical trial experience in the pharmaceutical industry or university hospital, with a minimum of 3 years' experience with the eTMF.
• A thorough and comprehensive practical knowledge of TMF processes, related standards, and its quality control.
• A thorough understanding of ICH-GCP quality standards and other relevant regulations.
• Proficiency with Microsoft Office, as well as practical experience with the electronic Trial Master File.
• Fluency in both oral and written English.
• An ability to work on multiple studies simultaneously.
• An excellent sense of self-organisation, along with time management skills, and an independent way of working.
• An ability to work within a team in a matrix organisation.
• Excellent problem-solving skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Andrea Rotmistrovsky on +44 203 854 0675 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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