NEHA PILLAI

Designed and configured EDC/eCRF workflows aligned with protocol-specific clinical study requirements. Developed and validated edit checks (range, logical, and conditional checks) to support data quality and integrity. Gained practical exposure to IWRS/randomization setup, subject allocation workflows, and EDC system configuration. Supported eDiary/ePRO setup for structured patient-reported data capture. Strengthened understanding of clinical data management, audit-ready documentation, and regulated eClinical workflows in a 21 CFR Part 11-compliant environment.

Supporting students for the Biomedical Engineering course named THERMODYNAMICS through office hours, review sessions, and facilitating discussions, leading to high subject proficiency among students. Provided detailed, constructive feedback on assignments and assessments, ensuring fair evaluation and fostering deeper understanding through tailored guidance.

SupportedBIOSTATISTICS course by assisting with data analysis, grading, and documentation review. Performed data validation and quality checks to ensure accuracy and consistency of academic records. Assisted in maintaining structured documentation and audit-ready records. Provided analytical support to students and clarified statistical and technical concepts. Collaborated with faculty to improve course delivery and student outcomes.

• Assisted in investigation and documentation of biomedical equipment issues in a hospital environment. Reviewed calibration logs, service records, and preventive maintenance documentation. Supported root cause analysis and corrective action documentation for device-related issues. Maintained equipment records to ensure compliance with hospital quality and safety standards. Gained exposure to regulatory documentation, equipment audits, and clinical engineering workflows.

Specialized in healthcare data analysis, biomedical systems, and clinical applications. Completed coursework in Biostatistics, Healthcare Informatics, Medical Devices, and Data Analytics. Worked on projects involving clinical data analysis, predictive modeling, and AI-based healthcare evaluation. Served as a Graduate Teaching Assistant for Biostatistics and Thermodynamics.