Marie E. Jean Gilles

Clinical Research Support & Data Operations

• Provided data management support for global multi-site clinical trials focused on HIV prevention and treatment.
• Designed and maintained Case Report Forms (CRFs) to ensure accurate and consistent clinical data capture across international research sites.
• Performed subject-level data review, query resolution, and data cleaning to maintain high-quality datasets for global studies.
• Participated in User Acceptance Testing (UAT), supported development of UAT plans, and documented system validation findings.
• Ensured completeness, accuracy, and protocol compliance of clinical trial data used in regulatory submissions and internal analyses.

Compliance & Documentation

• Authored Data Management Plans, CRF completion guidelines, and related documentation for global studies in alignment with Good Clinical Practice (GCP).
• Supported development of site initiation materials, site training resources, and data validation documentation used across study sites.

• Developed reproducible R scripts to perform statistical analyses, automate data cleaning, and generate custom dashboards, improving efficiency and data-driven decision-making.
• Programmed workflows to monitor key indicators, flag outliers, and visualize clinical and behavioral health trends for large-scale research studies.
• Standardized, harmonized, and mapped complex datasets for a genome-wide association study (GWAS) on obsessive-compulsive spectrum disorders, integrating data from 15+ international sites spanning two decades; contributed to biomarker discovery in a published study.
• Collaborated with multi-site research teams to define consistent data collection variables and perform cross-site harmonization, ensuring data integrity for reliable comparative and pooled analyses.
• Managed 30+ REDCap databases for psychiatric research involving 31,000+ participants, supporting robust data architecture and analytical readiness.

Technical Documentation & Quality Assurance

• Authored technical documentation, SOPs, and reproducible workflows for data extraction, cleaning, and analysis, supporting cross-functional collaboration and audit readiness.
• Performed quality assurance and control checks on data processes and outputs to ensure accuracy, reproducibility, and compliance with research standards.
• Effectively communicated data procedures and findings with internal research teams and external collaborators, enhancing transparency and facilitating informed decision-making

Clinical Data Programming & Visualization

• Used R and SAS to code, clean, and analyze data from over 11,000 participants in multi-site public health research studies.
• Developed automated reports and dashboards in R to visualize recruitment progress, questionnaire completion rates, and quality control metrics.
• Created reproducible pipelines for transforming raw questionnaire data into clean, analysis-ready datasets.
• Conducted in-depth data reviews to identify inconsistencies and implemented batch corrections and quality improvement measures.