I have extensive experience in clinical data auditing, having conducted over 50 audits across various therapeutic areas. My role involved ensuring compliance with regulatory requirements such as GCP and ICH guidelines. I have also developed audit protocols, performed data integrity assessments, and provided recommendations for process improvements to ensure data accuracy and reliability.

When identifying data discrepancies, I first document the issue thoroughly, including the source and nature of the discrepancy. I then collaborate with the relevant stakeholders to understand the root cause and propose corrective actions. My approach emphasizes transparency and collaboration to ensure that discrepancies are resolved efficiently and that similar issues are prevented in the future.

I am proficient in using tools such as SAS, SQL, and EDC systems like Medidata Rave and Oracle Clinical. These tools are essential for data extraction, analysis, and reporting during audits. Additionally, I have experience with audit management software like Trackwise and ArisG, which help in tracking audit findings and managing corrective actions.

Effective communication is key to ensuring that audit findings are understood and acted upon. I prepare detailed audit reports that clearly outline the findings, risks, and recommended actions. I also conduct debriefing sessions with stakeholders to discuss the findings and answer any questions. This approach ensures that all parties are aligned and committed to implementing necessary changes.

One challenging audit involved a study with significant data discrepancies across multiple sites. I initiated a comprehensive review of the data, involving site visits and interviews with site staff. By working closely with the study team, we identified systemic issues and implemented corrective actions, including additional training for site personnel. This collaborative approach led to the resolution of discrepancies and improved data quality for the study.