Hemalatha Karnati

Health Informatics graduate student with 2+ years of experience in clinical data management, data integration, and healthcare analytics within pharmaceutical and clinical research environments. Proficient in CDISC/SDTM, ICH-GCP, 21 CFR Part 11, EDC, SAS, and SQL, with a strong focus on data validation, quality assurance, and regulatory compliance. Skilled at translating complex clinical datasets into actionable insights that support regulatory submissions.

Associate Software Engineer at Saama Technologies Pvt. Ltd. (2022-03 – 2024-12)

• Integrated clinical and operational data from EDC, CTMS, and ePRO systems across multiple studies, improving data accessibility and reporting efficiency
• Annotated CRFs and mapped raw clinical data into CDISC-compliant SDTM datasets for regulatory submissions
• Generated transport files (XPT) and produced Pinnacle 21 validation reports for submission readiness
• Implemented data validation rules and quality checks to ensure accuracy, completeness, and consistency of clinical data
• Developed and maintained transformation mappings using Smart Auto Mapper (SAM) for clinical datasets
• Supported data review and reporting activities across Phase I, II, and III clinical trials
• Collaborated with clinical operations, data management, and programming teams on cross-functional deliverables
• Onboarded new studies and vendor data sources while ensuring adherence to clinical data standards

Clinical SAS Programmer Intern at Algorics Informatics Pvt. Ltd. (2021-11 – 2022-02)

• Developed SAS programs to import, transform, merge, and validate clinical trial datasets
• Mapped raw clinical datasets to CDISC SDTM standards
• Generated Tables, Listings, and Figures (TLFs) using SAS ODS in PDF, RTF, and HTML formats
• Interpreted CRFs and study protocols to support clinical data programming and reporting

Master of Science in Health Informatics – Governors State University (2026-12)

Bachelor of Pharmacy in Pharmacy – Vignan Institute of Pharmaceutical Sciences (JNTUH)