Head of Compliance & Audits

The head of Compliance and Audit’s primary mission is to provide assurance to the EORTC Directors that EORTC clinical trials and projects are meeting the utmost level of quality internally and externally, required per applicable processes and regulations.

Compliance & Audits cover 4 main area:

  • Internal audits
  • Audits of third parties (clinical trial sites, external vendors, CROs…)
  • Regulatory agencies inspections
  • Sponsor audits of EORTC

Main responsibilities / Major activities

  • Internal audits:
    • Responsible for designing and managing the internal audit process to ensure compliance with professional auditing standards
    • Oversees and support internal auditor staff by providing suitable recommendations for audit observations
    • Escalates, as appropriate, where resolution of audit findings is inadequate or where SOPs/process improvement might be advised
  • Audits of third parties:
    • Develops and implements an annual audit plan using appropriate risk-based methodology, including any risks or control concerns identified by management
    • Performs investigational site, external vendor and commercial partner audits and follow-up across Europe
  • Inspections and audits of EORTC
    • Ensures preparation and representation of EORTC during sponsor audits or Health Authorities inspections
    • Ensures appropriate communication of audit/inspection findings to Heads of Units/ Departments and follow-up of actions
  • General:
    • Provides support and advice to EORTC staff and partners in case of GCP issues
    • Organizes regular GCP training for HQ staff and members of EORTC network

Profile

  • University degree or equivalent in Health Sciences or relevant field
  • Thorough knowledge, understanding and experience applying ICH GCP Guidelines
  • 8+ years or relevant clinical research experience which includes at least 3+ years of direct GCP auditing experience
  • Experience with clinical CAPAs
  • Excellent presentation and communication skills
  • Experience in people management
  • Excellent organization and planning skills and attention to detail
  • Ability to work independently and within a team
  • Proactive, dynamic
  • Ability to travel across European countries
  • Fluent in English (oral and written), any other European language is an asset

Applications can be sent by email to info@hronegroup.com