Clinical Compliance Manager

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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 (, EMA, MHRA, FDA). The ideal candidate will serve as a subject matter authority on potential serious breach handling and support other activities related to QA across the clinical development portfolio.

What You'll Do:
• Lead the assessment and classification of serious breaches in collaboration with QA, Clinical Operations, and Regulatory Affairs.
• Serve as the primary point of contact for serious breach investigations.
• Prepare and submit serious breach notifications to applicable regulatory authorities within required timelines.
• Develop and maintain standard operating procedures ...