Tmf Manager

United Kingdom, United Kingdom

Job Description

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

Skills Required

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Job Detail

  • Job Id
    JD4302948
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    £40,000-45,000 per year
  • Employment Status
    Full Time
  • Job Location
    United Kingdom, United Kingdom
  • Education
    Not mentioned