Hildamary Thevar

I am a Senior Clinical Data Analyst and Regulatory Operations specialist with over 4.6 years of experience in oncology clinical trials, clinical research operations, and molecular diagnostics. I focus on ensuring data integrity, audit readiness, and regulatory compliance across CTMS and EDC platforms.

I have hands-on expertise in eRegulatory systems, IRB submissions, SOP development, and working knowledge of FDA, ICH-GCP, ICH E6(R2), and 21 CFR Part 11 standards. I consistently maintain above 95% QA accuracy in data submissions and support monitoring and audit activities.

My technical experience includes configuring and maintaining study protocols and documents in OnCore, Medidata Rave, CRDB, and CIBMTR, plus managing RWD/RWE datasets and performing clinical data abstraction, validation, reconciliation, and entry across multiple oncology indications.

I collaborate cross-functionally to streamline compliance processes, improve documentation workflows, and generate operational reports and metrics. I am open to roles in Data Coordination, CRA, CRC, or other clinical research and regulatory operations functions where I can drive quality and efficiency.