The Clinical Compliance Manager is responsible for the assessment, management, and reporting of serious breaches of GCP and protocol in clinical trials
Job Summary
The Clinical Compliance Manager is responsible for the assessment, management, and reporting of serious breaches of GCP and protocol in clinical trials.
This role ensures timely escalation, root cause analysis, regulatory communication, and CAPA tracking in alignment with global regulatory requirements.
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
Matching Summary
The Clinical Compliance Manager is responsible for the assessment, management, and reporting of serious breaches of GCP and protocol in clinical trials.
Skills & Requirements
Must-have
Serious breach assessment and management
GCP and protocol compliance
Root cause analysis and CAPA tracking
Regulatory communication and reporting
Clinical quality systems experience
Cross-functional collaboration
Nice-to-have
Training and mentoring experience
Strong leadership skills
Digital literacy and software proficiency
Flexibility and adaptability
Experience with Veeva Vault and TrackWise
Key Requirements
Bachelor’s degree in life sciences or related field
5+ years clinical research experience
2+ years in Clinical Quality or GCP Compliance
Strong knowledge of ICH E6(R2/R3) and EMA/MHRA/FDA serious breach expectations