Sonali patil

I am a Clinical Data Manager with experience across clinical data management, medical coding, and pharmacovigilance, focused on ensuring data integrity and regulatory compliance for clinical trials. I have worked on studies including diabetic retinopathy, breast cancer, and Alzheimer's disease, contributing to database setup, cleaning, and SAE reconciliation.

My background includes hands-on use of RAVE, Oracle, SpotFire, Imedidata, HCC Portal, and MedDRA coding, combined with strong Excel skills (pivot tables, macros) and experience performing UAT, edit checks, and migration activities. I have supported central laboratory services, coordinated with CROs and sponsors, and led training and documentation efforts.

I aim to deliver accurate, auditable clinical data through robust validation procedures, effective cross-functional collaboration, and attention to SOPs and regulatory guidelines (ICH-GCP, USFDA, CDSCO). I take responsibility for timely query resolution, metrics-driven cleaning, and smooth study closeout activities.