A specialist Medical Device and IVD Consultancy are looking for an experienced GCP Consultant to support with one of their IVD projects, specifically Companion Devices. This is a 12 month project, mainly remote although travel to clinical sites across the US and Europe will be required quarterly (expenses paid).
This project would be perfect for a contractor with previous experience managing IVD CPS studies and supporting with regulatory compliance and audit experience for clinical sites within the IVD space.
The Role:
- Ensure the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice (GCP) and the IVDR
- Site Qualification Visits and Site Initiation Visits - ensuring site compliance, proper implementation of study procedures, working closely with sponsor and site
- Verify site's adherence to GCP/GLP guidelines
- Performing interim monitoring visits, assessing progress and data accuracy
- Support with IVD documentation and protocols
Experience Required:
- Previous experience managing IVD CPS studies, including CPS notifications, applications, protocol drafting and review
- Drafting CR reports, CPS protocols
- Experience with combination products and companion devices
- Previous experience with companion devices with next gen sequencing would be ideal
We are looking to secure a contractor for this project as soon as possible so please apply or reach out to me on LinkedIn - Alicia Cliff. Interviews will be taking place this week (14th-16th August).