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Document Quality Coordinator

Posted by Phlexglobal Careers | Nov 7, 2018 6:58:52 PM

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

This position offers a fantastic opportunity to develop a career in document administration/management within the clinical research field.

We offer ongoing training and support throughout your time with us!

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:

  • Review and QC of the Trial Master File documentation according to client requirements
  • Devising filing structures for and indexing of client TMF 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
  • Have excellent working knowledge of clinical study documentation
  • Have advanced skills in Microsoft Office products (e.g. Outlook, Excel, Word, databases)
  • Proven experience in pharmaceutical development would be beneficial

We understand the need to balance work and life commitments and so are often able to accommodate flexible start and end times within certain core hours.

PXGUK376 Document Quality Co-ordinator
Permanent, Full time
Location: Chesham, Buckinghamshire

To Apply:

To apply please complete the below form or send your CV to quoting vacancy reference number PXGUK570 stating your minimum salary expectations and notice period.

Topics: United Kingdom, TMF Operations

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