Local Documentation Specialist - Junior CTA

Location
Berkshire (GB)
Salary
Competitive daily rate of pay
Posted
15 Jul 2019
Closes
12 Aug 2019
Ref
1507LTMFRS
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

DETAILS:

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Office based in Berkshire
  • Competitive daily rate of pay
  • Global pharma company

 

THE ROLE:

We are recruiting for a Local TMF Record Specialist to work as part of the Clinical Documentation Support Team in delivering an effective, efficient support and advisory service to the Clinical Research Team by ensuring the quality and integrity of the Trial Master File (TMF) meets inspection readiness standards.

  • Process CTMF documents in accordance with standards outlined by SOPs, local working instructions and ICH GCP standards to include production of submission sheets, tracking, scanning, importing and filing of electronic and hard copy documents
  • Periodic meetings with the TCM/CML to obtain an overview of studies and feedback on health/quality of the CTMF - Perform CTMF checks at agreed time points e.g. post study initiation and close-out, in accordance with company guidelines
  • Oversee recall of clinical trial documents from deep archive
  • Liaise with CMs to obtain permission to deep archive CTMFs and to obtain authorisation to destroy documentation once the retention period is exceeded
  • Coordinate the provision of documents required for internal audits and regulatory authority inspections and provide full support to any preparatory actives for inspections
  • Use an electronic filing system to maintain trial documents

Full job description available on application

 

THE CANDIDATE:

  • Previous experience in a similar role / TMF document specialist role / CTA role essential
  • Attention to detail
  • Use of Excel
  • Electronic filing systems
  • Ability to learn quickly
  • Understanding of clinical documents
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.