Posted on Sep 24, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Zurich we are looking for eTMF Associate for a 6 month contract.
Start date: 14/10/2019
Duration: 6 months
Support the development and other functions with tasks related to the electronic TMF (eTMF) quality control and maintenance. May follow up with functions on the eTMF quality issues until their resolution.
* Perform an ongoing technical quality control of the eTMF for documents uploaded by Development and other functions based on guidelines provided. Ensure quality control completion in the system.
* Escalate to the document owners or relevant functions any limiting factors and non-compliance related to the eTMF quality and may provide guidance on issue resolution.
* Monitor the eTMF quality control completeness and follow up with the document owners or relevant functions until their resolution.
* May arrange secure shipments of wet-ink documents.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
* Basic practical knowledge of TMF processes and its quality control guidelines
* Basic understanding of ICH-GCP quality standards and good documentation practice
* IT literacy, proficiency with Microsoft Office applications; practical experience with the electronic Trial Master File is not essential
* Ability to work on multiple studies simultaneously
* Pre-university education or Bachelor degree
* Fluent knowledge of spoken and written English.
* Good self-organization, time management skills, independent and structured way of working.
* Problem solving skills
For more information please contact Barbara Tenerowicz
E: (see below)