Country Clinical Quality Manager
msd · GBR - London - London (Moorgate WeWork)
Job description
About the role
We are seeking an experienced, proactive Country Clinical Quality Manager to lead clinical quality management for Clinical Trials Operations across the United Kingdom. In this role you will act as the strategic quality guardian for our sponsored clinical trials, safeguarding patient safety and data integrity.
Key responsibilities
- Act as the local authority on ICH‑GCP and evolving UK clinical trial regulations, partnering with Operations Management to maintain robust SOPs.
- Lead country‑level continuous quality improvement initiatives and contribute to regional and global projects.
- Serve as the primary contact for internal quality assurance bodies and regulatory agencies, preparing for inspections and managing CAPA plans.
- Coordinate in‑house quality control plans, conduct Quality Control Visits and ad‑hoc site evaluations.
- Lead escalation, investigation and root‑cause analysis of significant quality, compliance and privacy issues.
- Partner with Learning & Development to assess training needs and coach cross‑functional study teams.
- Manage quality evaluations and re‑qualifications of local vendors and clinical suppliers.
Required profile
- Bachelor’s degree in a relevant life‑sciences or healthcare discipline.
- 6–8+ years of clinical research experience, including field monitoring or oversight, preferably within UK Country Operations.
- Deep knowledge of ICH‑GCP, UK statutory requirements and end‑to‑end trial workflows.
- Proven experience in clinical quality management, audit preparation and process improvement.
- Strong analytical, problem‑solving and communication skills with high ethical integrity.
Required skills
- Clinical Quality Management
- Good Clinical Practice (GCP)
- Quality Control Management
- Regulatory Compliance
- Risk Management
- Performance Auditing
- Process Improvements
- Clinical Trials Monitoring
What we offer
- Direct influence over the safety and integrity of cutting‑edge clinical trials.
- Broad exposure to global clinical quality networks and continuous learning opportunities.
- An inclusive, mission‑driven culture backed by ethical leadership.
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Published 4 days ago
Expires 1 month from now
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msd
GBR - London - London (Moorgate WeWork)
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