I have extensive experience auditing clinical trials, having conducted over 50 audits across various phases and therapeutic areas. My background includes reviewing study protocols, monitoring plans, and regulatory documents to ensure compliance with GCP, ICH guidelines, and local regulations. I also have experience in identifying critical findings and providing actionable recommendations to improve study quality.

I approach conflicts by maintaining a professional and objective stance, focusing on the facts and ensuring open communication. I listen to all perspectives, seek clarification if needed, and work collaboratively to find a resolution that aligns with regulatory standards and study objectives. My goal is always to maintain a constructive relationship while upholding audit integrity.

I have utilized various audit management tools such as Trackwise, Arisg, and Veeva Vault. These platforms have been instrumental in tracking audit findings, managing corrective actions, and generating comprehensive audit reports. I am also familiar with electronic data capture systems and clinical trial management systems, which are essential for reviewing study data and processes.

I ensure compliance by thoroughly reviewing all relevant regulatory documents, including study protocols, informed consent forms, and investigator brochures. I also verify that all procedures align with GCP and ICH guidelines. During audits, I cross-reference findings with regulatory standards and provide detailed feedback to ensure all issues are addressed and corrected.

In one audit, I identified a critical issue with inadequate monitoring of adverse events, which posed a risk to patient safety. I worked closely with the study team to develop a corrective action plan, including enhanced training for site staff and revised monitoring procedures. This proactive approach ensured compliance and improved the overall quality of the study.