CRF QA Manager

Overview

In this role you will lead the Quality Assurance function for the Clinical Research Facility, ensuring compliance with regulatory and governance frameworks. You will develop and maintain SOPs, drive inspection readiness, and coordinate corrective actions across the CRF in collaboration with cross-site teams. You will use quality metrics to continually improve the CRF’s performance and support the Trust’s governance objectives. This is a pivotal position for shaping robust quality systems in a high-stakes clinical research environment.

Responsibilities

• Lead and maintain QA/quality management systems for the CRF
• Develop, implement and review SOPs, policies and working practices
• Monitor and risk-assess the CRF clinical trial portfolio
• Coordinate responses to findings and implement remedial actions
• Support MHRA, regulatory and Sponsor inspections; prepare inspection plans
• Maintain records ready for regulatory inspection
• Develop KPIs and quality metrics to drive improvement
• Promote a Quality Culture among staff and wider community
• Manage document management system for policies and essential documents
• Administer the CRF Quality Management System (QPulse) and use Trust reporting systems

Key requirements

• Degree level education; post-graduate certification in clinical research or equivalent experience
• Extensive experience coordinating or managing clinical research (phase I–III preferred)
• Up-to-date knowledge of major regulatory issues governing clinical research
• Experience managing a team
• Trained in ICH GCP (essential)

• Proven project management and organisational skills
• Excellent communication (oral, written, presentation)
• Self-motivated; able to work independently and exercise judgement
• QPulse; quality management system administration
• Use of Word, Excel, Access; internet tools
• Experience with regulatory reporting systems (EPJs, EPR, Datix)

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