Clinical Research Scientist
- Weybridge, Surrey (GBR)
- £70 - £90 Per Hour
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00092760
- clinical development
- regulatory affairs
- sop
- medical devices
- document management system
- project plan
Clinical Research Scientist
12 month contract
Weybridge
£90 per hour via umbrella
Lead and manage the preparation, review and approval of Clinical Evaluation Plan 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))
Responsible for being the point of contact with the Third-Party medical writing vendor
Key Responsibilities:
· Responsible for managing the process according to GSK CH SOP
· Accountable for managing the preparation review and timely completion and approval of the following documents:
o CEP, CER for the Medical devices
Preparation of these documents includes:
· Collect GSKCH available documentation and uploading in vendor electronic document management system
· Collect names of GSKCH 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 GSKCH/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
