- Location
- Maidenhead, United Kingdom
- Workplace
- Hybrid
- Type
- Full-time
- Education
- Bachelor
- Source
- Workday
Description
Location: London, UK (Hybrid – 2 days per week in the office)
Fortrea is seeking an Associate Country Clinical Quality Manager (ACCQM) to join our UK client-dedicated team.
This role is ideal for an experienced clinical quality professional who understands country and site-specific risks and is passionate about driving quality, compliance, and inspection readiness. In addition to strong clinical quality expertise, we are looking for individuals who embrace digital and AI-enabled ways of working, using data, automation, and technology to improve quality oversight, risk management, and operational efficiency.
As a trusted partner to country stakeholders, you will play a key role in safeguarding patient safety, data integrity, and regulatory compliance while helping to advance innovative, data-driven approaches to clinical quality management.
What you'll do
- Partner with country stakeholders to identify, assess, and mitigate quality and compliance risks.
- Support audits and regulatory inspections, including CAPA development, root cause analysis, and follow-up activities.
- Act as a subject matter expert in ICH-GCP, regulatory requirements, and quality management frameworks.
- Support the implementation, maintenance, and continuous improvement of SOPs and quality systems.
- Identify trends, risks, and opportunities for process improvement through data-driven analysis and quality metrics.
- Leverage digital tools, reporting solutions, and automation opportunities to strengthen quality oversight and operational effectiveness.
- Contribute to inspection readiness activities and compliance monitoring.
- Support training, knowledge sharing, and quality awareness initiatives across teams.
- Assist with Quality Control activities, including site-related quality reviews where required.
What we're looking for
- Bachelor's degree in Life Sciences, Healthcare, or a related field.
- Experience in clinical quality, compliance oversight, audits, inspections, or quality management activities.
- Experience with Power BI, Power Apps, automation tools, data analytics, or AI-enabled solutions.
- Exposure to audits, inspections, CAPA management, and quality investigations.
- Ability to identify risks, analyze trends, and drive continuous improvement.
- Interest in digital, data-driven, and AI-enabled approaches to quality management.
- Experience developing dashboards, metrics, or automated reporting.
Nice to have
- experience as a CRA or in a similar clinical research role.
- Experience supporting compliance investigations or quality issue management.
- Exposure to pharmacovigilance, privacy events, or serious breach reporting.
- Previous involvement in inspection readiness activities.
Why join us?
This is an opportunity to combine clinical quality expertise with innovative digital and AI-enabled ways of working. You'll help drive quality, compliance, and inspection readiness while leveraging technology, automation, and data to improve clinical trial oversight.
Learn more about our EEO & Accommodations request here.