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Danielle Howard Stewart

@daniellehowardstewar

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Clinical Trial Coordinator at MSD leading DRIVE AI, whose study meeting tool saves 300+ business hours monthly.

United Kingdom

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At Merck Sharp & Dohme (MSD), I co-founded and lead DRIVE AI, a cross-functional initiative bringing automation and AI into clinical operations. I designed a study-level KPI and meeting preparation tool that saves more than 300 business hours per month.

I also developed a mail-merge localisation workflow that reduces batch preparation to about five minutes, regardless of site volume. As a Responsible AI Steward, I support ethical AI adoption, and I maintain a central SharePoint hub for automation resources across UK clinical operations.

Earlier, I coordinated clinical research at Johns Hopkins University and Ann & Robert H. Lurie Children’s Hospital. At Lurie, I automated EMR data extraction, cutting the process timeline by half, and helped increase the department’s publication output by more than 100% through a strategic restructuring.

Experience

Work history, roles, and key accomplishments

Current

Clinical Trial Coordinator

Current

Merck Sharp & Dohme (MSD)

Aug 2024 - Present (2 years 1 month)

Co-founded and lead DRIVE AI, a cross-functional AI and automation initiative within GCTO UK's Productivity Pillar. Designed and implemented automation products, including a study-level KPI/Study Team Meeting preparation tool that saves 300+ business hours per month and a mail-merge localisation workflow that reduces batch preparation time to ~5 minutes.

AI Automation Power BI PowerApps Copilot Figma Process Automation SharePoint Clinical Vault ICH GCP Clinical Trial Operations Stakeholder Management Mentorship

Graduate Student Researcher

University of California, Berkeley

Jul 2023 - Sep 2023 (2 months)

Managed data-driven projects to facilitate hepatitis B drug development, presenting progress and insights to industry sponsors. Standardised data collection processes, creating SOPs for clinical trial information collection for new research projects.

Data Management SOP Development Clinical Research Hepatitis B Stakeholder Communication

Senior Research Program Coordinator

Johns Hopkins University

Oct 2020 - Aug 2021 (10 months)

Coordinated Phase I Zika Trials for the US National Institute of Health ensuring compliance with ICH-GCP standards. Led a cross-functional team of 10+ research assistants to execute laboratory and operational needs, including workflow creation and quality assurance.

ICH GCP Clinical Trial Operations Team Leadership Workflow Creation Quality Assurance Vendor coordination

Clinical Research Coordinator II

Ann & Robert H. Lurie Children's Hospital

Jul 2019 - Aug 2020 (1 year 1 month)

Led a strategic restructuring of the research group, including the development and implementation of a new strategic plan, resulting in an over 100% increase in publication output within the department. Automated electronic medical record (EMR) data extraction, reducing the process timeline from 3 months to 1.5 months (50% efficiency gain).

Strategic Planning EHR Data Extraction Process Automation User Research REDCap Qualtrics PHIS Training Collaboration

Education

Degrees, certifications, and relevant coursework

London School of Hygiene and Tropical Medicine

MSc, Epidemiology

Completed an MSc in Epidemiology at the London School of Hygiene and Tropical Medicine in 2023.

University of Edinburgh

MA (Honours), International Relations

Completed an MA (Honours) in International Relations at the University of Edinburgh in 2018.

CITI Program

Certification, Clinical Research

Earned certifications in Good Clinical Practice and ICH, Health Privacy Issues for Researchers, and the JHSPH Basic Human Subject Research Course in 2020.