GCP Consultant

1 month ago

Nationwide, United Kingdom X4 Group Ltd Full time

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)

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