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IVD Project GCP Advisor

2 months ago

Nationwide, United Kingdom X4 Group Ltd Full time

A prominent consultancy in the Medical Device and In Vitro Diagnostics (IVD) sector is seeking a knowledgeable GCP Consultant to assist with a significant IVD initiative, particularly focusing on Companion Devices.

This role spans a duration of 12 months and primarily offers remote work, although periodic travel to clinical sites in various regions will be necessary (expenses covered).


This opportunity is ideal for a contractor with a solid background in managing IVD Clinical Performance Studies (CPS) and possessing expertise in regulatory compliance and auditing for clinical sites within the IVD domain.


Key Responsibilities:
Ensure that the clinical performance study adheres to the Clinical Performance Study Plan, the principles of Good Clinical Practice (GCP), and the In Vitro Diagnostic Regulation (IVDR).
Conduct Site Qualification Visits and Site Initiation Visits to verify site compliance and the effective execution of study protocols, collaborating closely with both the sponsor and site personnel.
Monitor the site's compliance with GCP/GLP standards.
Perform interim monitoring visits to evaluate progress and data integrity.
Assist with the preparation of IVD documentation and study protocols.

Required Qualifications:
Demonstrated experience in managing IVD Clinical Performance Studies, including notifications, applications, and protocol development and review.
Proficient in drafting Clinical Report (CR) documents and CPS protocols.
Experience with combination products and companion devices is essential.
Familiarity with companion devices related to next-generation sequencing is highly desirable.


This consultancy is looking to onboard a contractor for this project promptly. Interested candidates are encouraged to submit their applications for consideration.