Certified Clinical Data Manager (CCDM®) with 12+ years of clinical data management expertise across the biotechnology, biopharmaceutical, and CRO industries. Currently Associate Director, Data Management at Intra-Cellular Therapies, supporting treatments for complex psychiatric and neurologic diseases — with active research on safe integration of AI/LLMs into clinical workflows.
I am a Certified Clinical Data Manager (CCDM®) with over 12 years of comprehensive clinical data management experience spanning biotechnology, biopharmaceutical, and CRO organizations. I currently serve as Associate Director, Data Management at Intra-Cellular Therapies, a company delivering treatments for people living with complex psychiatric and neurologic diseases.
Previously, I was Principal Data Manager at Shionogi Inc. My work spans end-to-end data management for global clinical trials — EDC, data quality, medical coding, and CDISC standards — alongside applied research on the safe, risk-managed integration of AI and large language models into clinical workflows.
Deep domain knowledge across the clinical data lifecycle and modern AI tooling.
End-to-end CDM: CRF design, edit checks, query management, database lock across Phase I–IV.
AI systems for clinical data review, anomaly detection, and intelligent automation.
Supervised & unsupervised ML, NLP for medical coding, predictive modeling on trial data.
GCP-compliant trial operations, protocol review, risk-based data monitoring.
SDTM & ADaM implementation, define.xml, controlled terminology, submission readiness.
Medical coding, dictionary management, coding consistency review and automation.
Statistical programming, data pipelines, validation, and reproducible analytics.
Real-world evidence, data visualization (Power BI, Tableau), regulatory compliance (21 CFR Part 11).
Published work on safe-by-design clinical LLMs and AI risk models for clinical workflows.
12+ years of clinical data management leadership across biotech, biopharma, and CRO.
Applied work in clinical data automation, AI-assisted review, and analytics.