Compliance & Audits Manager

The Compliance and Audits manager’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

  • Audits of third parties:
    • Develops and implements an annual audit program using appropriate risk-based methodology, including any risks or concerns identified by HQ staff involved
    • Performs external vendor audits and follow-up on CAPAs across Europe
    • Coordinates audits conducted by consultants on behalf of EORTC as applicable
  • Internal Audits:
    • Responsible for designing and managing the internal audit process to ensure compliance with professional auditing standards
    • Performs internal audits, including preparation, conduct , reporting and follow-up of the CAPAs
    • Escalates, as appropriate, where resolution of audit findings is inadequate or where SOPs/process improvement might be advised
  • 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 until CAPA closure
  • General:
    • Provides support and advice to EORTC staff and partners in case of GCP issues

Profile

  • University degree or equivalent in Health Sciences or relevant field
  • Thorough knowledge, understanding and experience applying ICH GCP Guidelines
  • 4+ years or relevant clinical research experience which includes at least 2+ years of 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