Nov 2023 – Present · 2 yrs 4 mos · Bengaluru, Karnataka, India · On-site

• As an Associate Clinical Data Programmer, I work on the end-to-end development and validation of clinical trial databases with a primary focus on Veeva CDMS (EDC & CDB).
• Key responsibilities and achievements include:
• 1) Designing and configuring Veeva EDC databases, including eCRF setup and database validation to ensure high-quality data capture.
• 2) Managing multiple Phase I trials across diverse therapeutic areas, consistently meeting aggressive timelines with exceptional time-management and multi-trial coordination skills.
• 3) Performing SDTM mapping in Data Management Workbench (DMW) to align trial data with CDISC standards for regulatory submissions.
• 4) Executing data ingestion, mapping, and transformation in Veeva CDB to support downstream statistical analysis.
• 5) Gaining working knowledge of Oracle INFORM EDC, enhancing flexibility across EDC platforms.
• 6) Collaborating with cross-functional teams to support database lock, data cleaning, and compliance with GCP and ICH guidelines.
• This role has strengthened my expertise in clinical data programming, database builds, and regulatory compliance, while allowing me to deliver high-quality datasets that accelerate clinical development.