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eTMF Specialist

Switzerland, Switzerland

  • Salary: Excellent package
  • Job type: Interim/Contract
  • Posted: 27/11/2018
  • Contact name: James Inwood
  • Contact number: 01892 612612
  • Ref: 3807

Job description

Hobson Prior is seeking an eTMF Specialist to support the development delivery functions at a leading pharmaceutical company in Switzerland. You will also be responsible for providing guidance on the eTMF process and supporting practically on how to use the system.

eTMF Specialist – Switzerland

Job Responsibilities

 

  • Carry out routine quality control checks of the eMTF, including checking compliance with the relevant requirements
  • Report any limiting factors or elements of non-compliance to the appropriate functions, providing comprehensive solutions
  • Provide process guidance on requirements according to the applicable SOPs, WIs, guidelines, and eTMF management plan
  • Practically support eTMF users in using the system
  • Review the eTMF management plans and provide input
  • Arrange shipments of wet-ink documents

Key Skills

  • Strong problem-solving skills
  • Excellent time management and ability to simultaneously work on multiple projects
  • Proficiency with Microsoft Office applications, and experience using the electronic Trial Master File
  • Thorough understanding of ICH-GCP quality standards and other relevant regulations

Requirements

  • BSc or equivalent, preferably in life science, clinical research or a related discipline
  • 5 years minimum clinical trial experience in the pharmaceutical industry or university hospital
  • 3 years minimum experience with the eTMF
  • Practical knowledge of TMF processes and related standards, and their quality control

 

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 specialist life science 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.