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Job Details

Document Quality Co-ordinator 6 month FTC - immediate start

Company: Phlexglobal
Location: Chesham, Bucks, HP5 2FW
Reference: PXGUK471
Closing Date: 28 Aug 17
Type: Contract
Salary (£): Competitive

Job Summary:

We have an opportunity to join our TMF Readiness department to help with ongoing project work.


The opportunity:

An exciting opportunity to join Phlexglobal as a Document Quality Co-ordinator in our TMF Readiness department.

This is a fixed-term contract position working on a global, large scale project.

The role:

We are looking for individuals with hands on experience in clinical trial administration, providing 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 excellent essential study document recognition skills.

A full job description will be provided ahead of interviews but in brief, your role will include:

  • Remap of TMF documentation in to different filing structure(s)
  • Pre audit/inspection review of the Trial Master File documentation
  • Set up of TMF and Investigator Site Files
  • Scanning and indexing of client study documentation
  • Training and mentoring other employees as appropriate

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

The ideal candidate will:

  • ?Have excellent knowledge of ICH GCP and the EU Directives
  • At least 12 months of direct experience with TMF (paper or electronic)
  • Previous clinical research experience (CTA, Site Coordinator), etc.
  • Have advanced skills in Microsoft Office products (e.g. Outlook, Excel, Word, databases)

We understand the need to balance work and life commitments and can sometimes accommodate more flexible start and finish times within the core hours of the role. If this is of particular interest to you, please discuss this with us before submitting your application.

To Apply:

Please apply quoting vacancy reference number PXGUK471stating your minimum salary expectations.

This position is office-based in Chesham, Buckinghamshire. 

Why Work for Phlexglobal?

We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalised career development opportunities.

Our benefits typically include a competitive base salary, generous annual leave and flexible working arrangements. We also provide pension, private medical insurance and life assurance, as well as access to many other benefits including our exclusive retail and gym membership discounts scheme (subject to eligibility).

Your career and personal development is important to us. We provide you with all the training you need to develop the knowledge and skills to be successful at work. We also provide personalised learning and development plans, access to our training and professional development programmes, and regular performance reviews to enable you to achieve your career development goals.

All our benefits are subject to the terms and conditions of your employment.

Apply for this job: Document Quality Co-ordinator 6 month FTC - immediate start

Contact Information:

Address:  Head Office
Mandeville House
62 The Broadway
Tel:  +44 (0)1494 720420
Website:  Visit Our Web Site

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