Clinical Trials Associate (CTA) - High Wycombe

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  • PharmaTimes Top 50 growing company
  • Medium sized business with a friendly environment
  • Recent expansions driving their recruitment

Are you a Clinical Trial Assistant (CTA) or Clinical Trial Coordinator seeking career development? Zest Scientific Recruitment has been instructed to oversee a team build of candidates with professional experience in a CTA or similar level role. It’s essential that candidates demonstrate Trial Master File (TMF) and Document Management experience.  This is an office based role with some flexibility to be home based after training, where you will interact with local Project Managers (global pharmaceutical partner) as the subject matter expert, taking ownership of TMF from set up to close out.

                                                                                                                                                         

The Candidate:

  • Clinical Trials experience with a focus on Clinical Documentation Management.
  • Knowledge of the processes associated with the conduct of clinical trials and document management operations.
  • Ability to interact effectively and represent the company with a client partner. The TMF Study Owner will be assigned early on in a study and work closely with the Project Manager to provide training to study team members and qualify requirements and expectations.
  • Comfortable working with Microsoft Excel.
  • Leveraging influence, coordinating peers and when needed be assertive to ensure key milestones are achieved.
  • Happy working in a remote / home office environment.

 

The Role:

  • The CTA is the subject matter expert for the TMF and ISF, seeing a project through to completion.
  • You will lead the set up of the TMF and ensure that all relevant documentation meets regulatory requirements until study close out.
  • Interact with the Study Team (primarily Project Manager), provide training and qualify expectations.
  • Create placeholders within the eTMF so the study team can file their documents. You will ensure that the study team is accountable for filing SSDLs in a timely fashion.
  • At the end of the study, review the placeholders and ensure that relevant documentation is present. Following review, approval is provided to close the study from eTMF.

 

The Company:

  • Globally recognized as an industry leader providing Clinical Research solutions into Pharmaceutical, CROs and Biotechnology.
  • Supports continued professional development and will provide long term opportunities for career enhancement.
  • Supports home office / remote working.
  • Leader in the provision of cloud based technology and services into the Clinical Trials sector. 

Zest Scientific is working to a strict deadline so in order to be considered for this opportunity please apply now and your application will be reviewed immediately.