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Clinical Operations - Clinical Research General
Ref: 1049 Date Posted: Wednesday 11 Jul 2018
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Entrust People are currently recruiting on behalf of their client based in Chesham for a permanent Document Quality Specialist (CTA) who is fluent in Japanese.  Initial training will be based in Chesham however there is flexibility to work from home once training is complete.

Are you an experienced CTA with expert knowledge of the Trial Master File (TMF) looking for something different?

The role
We are looking for individuals with hands on experience of every stage of the critical path of a clinical trial to provide logistical support to a number of projects. Candidates should have a good understanding of the Trial Master File (TMF), the Investigator Site File (ISF) and essential study documentation. 

A full job description will be provided ahead of interviews but in brief, your role will include:
• Pre audit/inspection review of Client Trial Master File documentation electronically.
• Devising new filing structures as well as basic filing maintenance (electronic and hard copy)
• Scanning and indexing of client study documentation
• Training and mentoring other employees as appropriate
• To work with the Readiness Leader on existing projects and to take the lead in delegated projects where skills and competencies allow

We need individuals who are:
• Able to work to deadlines in a fast paced environment, prioritising their work and multi-tasking!
• Proactive, able to work independently, diligent and self-motivated
• Focused and have excellent attention to detail
• Experienced with remote based working.

The ideal candidate will have:
• Excellent Japanese and English language skills
• Excellent knowledge of ICH GCP and the EU Directives
• Excellent working knowledge of clinical study documentation
• eTMF experience.
• Advanced skills in Microsoft Office products (e.g. Outlook, Excel, Word, databases)