RBW Consulting are excited to announce an opportunity on behalf of our close client. This company are a small, UK-based CRO who have won new projects recently and are looking to grow their clinical operations team.
Responsibilities
- Manage TMF lifecycle: Set up, maintain, and archive eTMF in compliance with ICH-GCP and DIA TMF Reference Model.
- Ensure quality and compliance: Perform QC checks, resolve discrepancies, and maintain inspection readiness.
- Act as TMF SME: Provide guidance to internal teams and vendors; monitor KPIs and report status.
- Support audits and inspections: Prepare TMF, respond to queries, and implement corrective actions.
- Drive process improvements: Enhance TMF systems, update SOPs, and train staff on best practices.
Ideal Background
- Comprehensive understanding of TMF procedure, regulatory requirements and GCP
- Extensive experience of clinical trial documentation and reporting
- Experience using two or more eTMF systems