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Job Details

E-TMF Specialist - Zurich, Switzerland

Company: CK Clinical
Location: Switzerland
Reference: CL40513
Closing Date: 30 Nov 17
Type: Contract
Salary (£): Competitive

Job Summary:

Jocelyn Blackham is currently recruiting for an eTMF Specialist to join an innovative target based drug discovery team for an international pharmaceutical company based in...


Jocelyn Blackham is currently recruiting for an eTMF Specialist to join an innovative target based drug discovery team for an international pharmaceutical company based in Zurich, Switzerland. This role is offered on a part time temporary basis for 6 months, with the possibility of extension. The role is offered on a 4 day week.

Your main responsibilities will be to support the development delivery functions with tasks related to the eTMF quality control and maintenance. Responsibilities will also include:
• Performing 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
• Escalating to the relevant functions any limiting factors and non-compliance related to the eTMF quality and provide comprehensive guidance on issue resolution
• Monitoring the eTMF quality issues and follow 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. Providing practical support to eTMF users on the use of the system
• Contributing to the revisions of the eTMF process and system enhancements 
• Arranging secure shipments of wet-ink documents 
• Providing support by eTMF related audit or inspections  

You are 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
• Previous experience with clinical trial in the pharmaceutical industry or university hospital, with experience with the eTMF, would be advantageous
• 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 
• Excellent problem solving skills   

If you are employed by this client you will be joining a international pharmaceutical company based in Zurich, Switzerland. 

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40513 in all correspondence.

Apply for this job: E-TMF Specialist - Zurich, Switzerland

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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