Curriculum Vitae

Clinical Data Management • Artificial Intelligence • Healthcare Analytics

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Professional Summary

Certified Clinical Data Manager (CCDM®) and SAS Base certified professional with over 12 years of comprehensive clinical data management expertise in the biotechnology, biopharmaceutical, and CRO industries. Currently Associate Director, Data Management at Intra-Cellular Therapies, supporting clinical programs for complex psychiatric and neurologic diseases. Experienced across the full data lifecycle — study startup, EDC, data validation, medical coding, and database lock — with published research on safe integration of AI/LLMs into clinical workflows.

Core Competencies

Clinical Data ManagementCDISC SDTM/ADaM MedDRA / WHODrug CodingEDC (Rave, InForm, Veeva) Machine LearningNLP SASPythonRSQL Risk-Based Monitoring21 CFR Part 11 / GCP Power BI / TableauDatabase Lock
Career

Work Experience

Present

Associate Director, Data Management

Intra-Cellular Therapies · Parsippany, NJ
  • Lead data management for clinical programs in complex psychiatric and neurologic diseases.
  • Oversee end-to-end CDM strategy: EDC setup, data validation, medical coding, and database lock.
  • Drive data quality, vendor oversight, and inspection-readiness across studies.
Prior Role

Principal Data Manager

Shionogi Inc.
  • Managed end-to-end data lifecycle for global clinical trials, from study startup to database lock.
  • Led CRF design, edit-check specifications, query management, and coding reviews.
  • Coordinated with biostatistics, programming, and CRO partners on deliverables and timelines.
Earlier Career

Clinical Data Management Roles — Biotech, Biopharma & CRO

12+ years of progressive CDM experience
  • Progressed through hands-on data management roles across the biotechnology, biopharmaceutical, and CRO industries.
  • Built expertise in EDC systems, SAS programming, data validation, and CDISC standards.

Education

B.Pharm — Bachelor of Pharmacy

St. Peter's College of Pharmacy · 2007 – 2011

Foundation in pharmacology, pharmaceutics, and clinical research principles.

Technical Skills & Software

Software Expertise

Medidata Rave · Oracle InForm · Veeva CDMS · SAS 9.4 / SAS Viya · Pinnacle 21 · JMP · Power BI · Tableau · Jira · Git

Programming Languages

SAS · Python (pandas, scikit-learn, PyTorch) · R · SQL · JavaScript (basic)

Standards & Regulations

CDISC (SDTM, ADaM, CDASH, define.xml) · MedDRA · WHODrug · ICH-GCP · 21 CFR Part 11 · GDPR/HIPAA

Credentials & Highlights

  • Certified Clinical Data Manager (CCDM®) — Society for Clinical Data Management
  • SAS Base Certified Professional
  • Published author — AI/LLM safety in clinical workflows (2025)
  • 12+ years across biotechnology, biopharmaceutical, and CRO industries

Professional Memberships

  • Society for Clinical Data Management (SCDM) — CCDM® credential holder
  • Add other memberships here (e.g., DIA, ACDM) as applicable.