Michelle Leavy

About Michelle Leavy

I am an epidemiologist and real-world evidence (RWE) researcher with over 20 years of experience designing and conducting observational studies to inform clinical and policy decisionmaking. Throughout my career, I’ve led large-scale, multi-institutional research initiatives that have supported regulatory, reimbursement, and clinical decision-making.At OM1, I spearheaded the Registries Center of Excellence at OM1, providing strategic oversight for prospective observational research studies. My work focuses on optimizing study design, ensuring methodological rigor, and aligning research initiatives with regulatory and scientific best practices. I have a proven track record of integrating emerging technologies—including natural language processing (NLP) and artificial intelligence (AI)—into epidemiological research, streamlining data extraction and improving real-world data quality.My expertise spans- Observational study design and execution- Cross-functional team leadership- Regulatory and post-market surveillance research- Application of NLP/AI to enhance RWE studies- Scientific publication and peer reviewI am a senior editor and author for the AHRQ’s Registries for Evaluating Patient Outcomes: A User’s Guide and have contributed to federal research initiatives and published extensively in peer-reviewed journals. Through my work, I aim to improve the generation and interpretation of real-world evidence to support healthcare decision-making.Contact me at m••••••••@gmail.com to discuss advancing rigorous, real-world research.

Experience

1. Senior Director, Registries & Real-world Evidence

   Om1, Inc

   Mar 2024 — Present · Portland, ME, US

Education

• University of North Carolina at Chapel Hill

  Master of Public Health - MPH

• Columbia University in the City of New York

  Bachelor of Arts (BA)

Skills

• CRO
• Research
• Clinical Research
• Oncology
• Clinical Trials
• Epidemiology
• Gcp
• Life Sciences