Are you an experienced CTA with expert knowledge of the Trial Master File (TMF)? Are you fluent in Japanese and looking for a fresh challenge or something different?
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 mainly focussing on our Japanese clients. Candidates should have a good understanding of the Trial Master File (TMF), the Investigator Site File (ISF) and essential study documentation. This role can be remote based in the UK or Phlexglobal office based.
- 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 Phlexglobal 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 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)
PXGUK550 Experienced CTA (Japanese Speaking)
Permanent, Full Time
Location: Home Based/Chesham, Buckinghamshire
To apply please send your CV to firstname.lastname@example.org quoting vacancy reference number PXGUK550, stating your minimum salary expectations and notice period.