Clinical Compliance Expert

3 days ago


Dublin, Dublin City, Ireland TN Ireland Full time

At TN Ireland, we are seeking an experienced Clinical Compliance Expert to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of clinical quality and compliance in our clinical trials.

About the Role:
  • Serve as the lead Clinical Quality Business Partner for assigned clinical trial programs, handling multiple projects and ensuring timely completion of tasks.
  • Act as Subject Matter Expert performing global risk assessment for investigator site and vendor audit planning.
  • Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.

The ideal candidate will possess expert knowledge of Good Clinical Practice (GCP) and strong project management and communication skills. You will work closely with clinical study management teams to provide expert clinical compliance information and support continuous improvement.

Requirements:
  • BA or BS and 10+ years of relevant experience.
  • At least 6 years of audit and compliance experience.
  • Must have significant GCP audit and compliance experience.
  • Bio-pharma sponsor experience preferred.
  • Recognized as an expert resource on a range of clinical compliance topics.


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