GVP Auditor

We''re recruiting for a globally respected CRO seeking a UK-based Remote GCP Auditor. This role ensures patient safety and regulatory compliance across international clinical trials through expert auditing of clinical sites, processes, and documentation. Core Responsibilities Conduct Risk-Based Audits: Lead remote audits of Clinical Investigator Sites, Vendors (Labs, CROs), TMF/eTMF, and Clinical Systems across UK/EU Apply risk-based methodologies to prioritize audit targets Ensure Regulatory Compliance: Verify adherence to ICH-GCP, UK Clinical Trials Regulations, MHRA requirements, and GDPR Monitor CAPA effectiveness post-audit/inspection Audit Management: Issue detailed audit reports (critical/major/minor findings) via eQMS (e.g., Veeva) Maintain comprehensive audit documentation Support Inspections: Host/support MHRA, EMA, and FDA inspections as GCP subject matter expert Training and Collaboration: Deliver GCP training to clinical teams Advise on quality issues with Clinical Operations and Data Management Essential Requirements Residency: Must be UK-based with right to work Education: Bachelor''s/Master''s in Life Sciences or related field Experience: 3+ years GCP auditing in CROs/Pharma Proven experience auditing Clinical Sites and TMF Regulatory Knowledge: ICH-GCP, UK Clinical Trials Regulations, MHRA expectations Technical Skills: eQMS (Veeva preferred), MS Office, remote auditing tools Language: Fluent English ..... full job details .....
Perform a fresh search...
-
Create your ideal job search criteria by
completing our quick and simple form and
receive daily job alerts tailored to you!