Describe a time when you led a cross‑functional team to resolve a critical data integrity issue during a clinical trial. How did you approach the situation, what actions did you take, and what was the outcome?

Use STAR: 1) Situation – brief context of the data integrity breach. 2) Task – your leadership role and objectives. 3) Action – step‑by‑step actions (root cause analysis, stakeholder alignment, CAPA implementation, data audit, communication plan). 4) Result – measurable impact (e.g., % of data restored, regulatory audit pass, timeline shortened). Keep within 120‑150 words, focus on leadership decisions, stakeholder engagement, and data governance.

During a Phase III oncology trial, I discovered that 12% of patient lab records were missing critical values due to a mis‑configured data extraction rule. As the Clinical Data Analyst Lead, I assembled a cross‑functional team of data engineers, statisticians, and regulatory affairs. We performed a root cause analysis using the RICE framework, prioritized corrective actions, and executed a CAPA that involved re‑running the ETL, re‑validating data, and updating the Data Management Plan. I maintained transparent communication with the sponsor and IRB, providing daily status updates. The issue was resolved 48 hours ahead of schedule, the audit passed without findings, and the trial remained on track, preserving the projected $5M budget.