Real-world examples of delivering value in clinical data projects for current and previous clients. These are not exhaustive, and do not include projects during full-time employment. Additional examples are available upon request and cover areas of imaging (DICOM) data management, leveraging use of additonal R Shiny dashboards and Quarto reports, use of AWS / GCP for storage, transfers and compute projects.
Led comprehensive data management for a multi-site, multi-country Phase I and II oncology trials in colorectal cancer, and hepatocellular carcinoma. Complex, adaptive EDC design with stratified randomization
Challenge: Fragmented vendor landscape, complex EDC design, and limited data standardization.
Key achievements: 3 EDC builds, 1 migration, optimized vendor selection and oversight, and delivered consistent analytics and reporting for the study teams. Ownership and delivery of all key CDM documents (including but not limited to eCRFs, Edit checks, DTAs, DMP, Coding docs, SAE reconciliation)
Designed and implemented technical workflows for biospecimen disposition, sample returns, and operational KPIs for external / pharma partnerships.
Key achievements: Built a reusable, human-in-the-loop analytics pipeline for biospecimen reporting, reducing manual effort by 90% across 3 deliverables.
Built an end-to-end automated patient profile review system for a large, multi-site, clinical trial with complex oncology elements.
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