Sivaranjani S

Clinical Data Analyst @ConcertAI

Bengaluru, IN

Conducted basic and advanced clinical data reviews on over patient records, maintaining 99.5% data accuracy through rigorous quality checks and collaboration with the Quality Control team.• Conducted CRF review, data cleaning, discrepancy management, SAE handling, and reconciliation, ensuring strict adherence to ICH-GCP guidelines, SOPs, and study protocols.• Proficient in EDC systems and clinical data workflows, contributing to accurate data capture and query resolution.• Collaborated with Quality Control (QC) and analytics teams to perform discrepancy management, edit check reviews and 100% data quality checks, ensuring timely resolution of data clarification requests in line with the Data Management Plan (DMP) and study protocols.• Reviewed and captured adverse events and concomitant medications using MedDRA and WHO Drug Dictionary to ensure consistency and accuracy.• Conducted presentations and training sessions to communicate updates in data analysis workflows and abstraction protocols, enhancing team alignment, reducing data discrepancies during protocol transitions and consistently delivering high-quality deliverable.• Maintained regulatory compliance through strict adherence to GCP, SOPs and WPDs.• Streamlined abstraction protocols and implemented automated quality checks, improving data delivery timelines by 30% across multiple high-impact studies.• Recognized by senior management as a top-performing Quality Analyst for maintaining 100% data accuracy and delivering high-quality medical abstractions with superior productivity across oncology RWD projects.• Contributed to the successful delivery of real-world evidence (RWE) datasets across 10+ oncology research studies, enabling actionable insights into treatment patterns, clinical outcomes and disease progression.