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Trial Master File Lead

Employer
CK Group
Location
Lausanne
Salary
Competitive
Closing date
19 Feb 2022

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Sector
Clinical Research / Trials
Contract Type
Contract
Hours
Full Time
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Job Details

Jocelyn Blackham is recruiting for a Trial Master File Lead to join an innovative Swiss Biopharmaceutical company in the industry at their site based in Lausanne on a contract basis for 24 months. This role can be offered on a remote basis.

Trial Master File Lead Role:
- Develop and improve work processes and systems to support document management, including contributing to SOPs and internal department guidance
- Promote harmonization of document filing and eTMF management across departments
- Supervise the TMF champions initiative and setup of the TMF specialist organisation & management
- Act as Line Manager of the TMF Specialists (2-3 people); managing their workload, prioritizing their activities

Key duties will include:
- Owning and maintaining the Quality Control process of the eTMF; ensure users training and appropriate process execution
- Analysing eTMF issue trends and escalating concerns, and supervising implementation of Corrective/Preventive Action
- Providing support during audits, due diligences and inspections

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University/College degree level or equivalent in a relevant discipline
- Previous experience in the Pharmaceutical Industry or CRO with previous experience with clinical documents management (process and execution level) in clinical research with good knowledge of TMF, GCP and drug development.
- Extensive knowledge and application of the TMF Reference Model, ALCOA-C standard, Good Clinical Practice (ICH GCP E6 (R2), FDA 21 CFR Part 11), Good Documentation Practices and any other relevant are preferred
- Previous experience in people management highly preferable or previous involvement in team members’ coaching
- Fluency in English required (C1), French is an advantage

This is an excellent opportunity to join an exciting Swiss biopharmaceutical company.

For more information or to apply for this position, please contact Jocelyn on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 52700 in all correspondence.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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