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Hire Avni D.

United States

USD 350 /hr

Healthcare Regulatory SME & Data Strategist | Clinical Quality, Digital Transformation & Process Optimization

Profile Summary

About Me: I am a transformative healthcare leader, regulatory Subject Matter Expert (SME), and data-focused operational architect with over 15 years of experience driving clinical quality, digital transformation, and compliance across complex healthcare systems. My career spans impactful roles at Deloitte Consulting, the National Institutes of Health (NIH), Georgetown University, and within major hospital systems. I specialize in bridging the gap between intricate clinical data, federal health policy, and cutting-edge healthcare technologies. As a consultant, I help organizations optimize clinical workflows, achieve rigorous regulatory readiness, and leverage data analytics to improve patient safety and business outcomes. Notably, I have designed and commercialized a $10M revenue-generating health dashboard that influenced federal policy, led digital transformation initiatives that slashed regulatory process steps by 90%, and directed the validation of AI-generated medical summaries to ensure clinical reliability. Areas of Expertise: Regulatory Compliance & Strategy: Federal health consulting, CMS Conditions of Participation, The Joint Commission standards, IRB compliance, and state/national regulatory readiness. Healthcare Data Analytics & Digital Health: Advanced data visualization, dashboard development, predictive analytics, outcome measurement, and AI-generated medical summary validation. Clinical Quality & Patient Safety: High-Reliability Organization (HRO) principles, evidence-based care pathways, clinical workflow optimization, and risk mitigation. Scientific Research Management: Scaling research portfolios, clinical data integration, epidemiological studies, and securing study funding. Whether you need a trusted advisor to navigate complex federal health regulations, an expert to validate emerging medical AI technologies, or a data strategist to build clinical dashboards, I deliver measurable, high-impact solutions that ensure compliance and excellence.

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Data Visualization
• ☆ Clinical Trials
• ☆ Clinical Trials
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Public Health
• ☆ Epidemiology
• ☆ Environmental Epidemiology
• ☆ Tobacco Use Prevention & Control
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Regulatory Affairs
• ☆ Six Sigma

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Creative Writing

Research Market Research, Gap Analysis

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting

Data & AI Data Visualization, Data Cleaning, Data Processing, Data Insights

Work Experience

Director

CGI

December 2025 - Present

Education

Certificate Masters

Georgetown University

August 2011 - May 2013

MPH

Columbia University

August 2006 - January 2008

Certifications

• Lean Six Sigma

  Maryland Hospital Association

  January 2026 - Present

• PMP

  PMI.org

  January 2025 - Present