Join Us as a Clinical Compliance Manager - Make an Impact at the Forefront of Innovation

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 (e.g., 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 (SOPs) related to breach management.

• Ensure timely and thorough root cause analysis and CAPA development, working closely with functional area leads.

• Maintain breach documentation and logs in compliance with GCP and inspection expectations.

• Support audits and regulatory inspections as a subject matter expert (SME) for serious breach.

• Deliver training and guidance to study teams and sites on breach awareness and reporting procedures.

• Trend and report breach data to identify process improvements or systemic quality issues.

Education & Experience Requirements:

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.

• 5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.

• Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA serious breach expectations.

• Proven experience in CAPA, root cause analysis, and deviation management.

• Demonstrated ability to communicate complex compliance issues clearly and effectively.

• Comfortable working in a matrix organization and managing cross-functional customers.

• Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is a plus.