eTMF Specialist

  • Salary: Competitive
  • REF Number: 00047148
  • Consultant: Alex Tosney
  • Contact: +41 (0) 782 508 535
  • Date Published: 03.12.2019
  • Sector: Vaccines
  • Location: Zurich/Zug Region
  • Discipline: Clinical - Data Management

Alex Tosney is recruiting for a number of eTMF Specialist's to join a company in the pharmaceutical industry at their site based in canton of Zürich on a contract basis for 6 months.

The main purpose of the role will be to:

  • Complete 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 inclusive guidance on issue resolution.
  • Monitor the eTMF quality issues and follow up with the relevant functions (sponsor/vendor) until their resolution.

Further responsibilities will include:

  • Proving regular eTMF processing guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan. Giving practical support to eTMF users on the use of the system.
  • Contributing to the revisions of the eTMF process and system enhancements.
  • Carrying out reviews of the eTMF management plans and provide relevant input.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Bachelor degree or equivalent, preferably in life science, clinical research, 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.

This is an excellent opportunity to join an expanding pharmaceutical company within their vaccines unit.

For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 782 508 443 or email atosney@ckqls.ch. Please quote reference 47148 in all correspondence.

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