Sunita Gowda

About Sunita Gowda

Passionate Clinical trial professional with strong knowledge and clear understanding of study startup, study conduct and study close out process. I am passionate about driving end to end data integrity and quality in clinical research, collaborating closely with cross-functional teams including clinical operations, biostatistics, and regulatory affairs. My goal is to streamline data processes, minimize risks, and contribute to the successful delivery of new therapies that improve patient outcomes.** Part of multiple studies that have been conducted for therapeutic area such as Oncology treatment, Pain relief, and Hematology treatment**Have hands on experience in study start up activity such as protocol review, eCRF design, and edit checks.**QASH -ensuring quality, compliance, and reconciliation of samples and associated data.** QDR and MDR activities**Create and review forms and edit checks by creating dummy data to evaluate EDC functionality.** End to end knowledge of data collection, and query management.**Executed the plan as per the SOP and regulatory guidance.**Co-Ordinating with Project management Team for compliance with the Sponsor requirement and timelines** Close Co-ordinating with Investigators and PI *Expertise in clinical Trial Management System (CTMS) & Electronic Data Capture (EDC) Systems and adverse reporting.**Skilled in applying ICH-GCP guidelines and familiar with CDISC/CDM processes, with certifications in Clinical Data Management and Good Clinical Practice (GCP).**Thorough knowledge in 21 CFR part 11 ** Handled Sponsor audit and regulatory Auditlooking for the Associate level roles in CDM #cdm #regulatory affairs ##cro #medical Writing #project Management

Experience

1. Regulatory Affairs Associate

   Merck Group

   Jan 2026 — Present

Education

• Rajiv Gandhi University of Health Sciences (RGUHS)

  Master's degree, Pharmaceutical Sciences

• Rajiv Gandhi University of Health Sciences (RGUHS)

  Bachelor of Pharmacy - BPharm, Pharmacy