Clinical Research Scientist

Clinical Research Scientist

Clinical Life Sciences

Location Surrey

Contract Contract

Reference HT12CRSG

Date Posted

Consultant


CY Partners have a fantastic opportunity to work with a world-leading global Healthcare Organisation, as a Clinical Research Scientist focused on working within the Medical Device area. The role will involve a mix of site based from their site in Surrey and home working initially.

As a Clinical Research Scientist, you will have the opportunity to lead and manage the preparation, review and approval of Clinical Evaluation Plans and Reports for European Medical Devices, in close cooperation with contributors from relevant functional roles (e.g. Global Regulatory Affairs, Category Medical Affairs, Category Clinical Development, Safety Evaluation and Risk Management (SERM))

As Clinical Research Scientist you will also be responsible for being the point of contact with the Third-Party medical writing vendor.

Other key responsibilities include:

  • Responsible for managing the process according to SOP
  • Accountable for managing the preparation review and timely completion and approval of the following documents: CEP, CER for the Medical devices.

Preparation of these documents includes:

  • Collect available documentation and uploading in vendor electronic document management system
  • Collect names of functional team members
  • Manage copyright clearance with vendor as needed
  • Provide support & coordination for literature search as needed
  • Develop project plan with timelines for each review by the organisation/vendor
  • Communicate and escalate issues
  • Regularly follow up with functional team members to ensure timelines are met
  • Send documents for review and approval in the electronic document management system

Previous experience in managing clinical documents and projects is highly desirable. This opportunity is initially available as a 12 month contract, with great potential for further opportunities moving forward.

For further information and a confidential chat about the opportunity, contact Helen Tomlinson at CY Partners on 07851246847 or apply with an up to date version of your CV to [email protected]

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Clinical Research Scientist

Clinical Life Sciences

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