Associate Data Team Lead

Supported and coordinated all study start-up activities in clinical data management, including CRF design, edit check specification development, and database setup as per protocol and standards

Contributed to preparation and review of Data Management Plan (DMP), Data Validation Plan (DVP), Data Review Plan (DRP), and Data Transfer Specifications (DTS)

Performed user acceptance testing for database build and edit checks, documented issues, coordinated resolutions, and ensured timely database go-live

Assisted in annotated CRF preparation and validation to support CDISC/CDASH submission compliance

Supported external vendor data setup for lab, imaging, and PK data, ensuring specification finalization and data transfer mechanisms

Collaborated with biostatistics, programming, clinical operations, and medical monitoring teams for database activation readiness

Maintained study documentation according to SOPs and regulatory requirements (ICH-GCP, 21 CFR Part 11)

Monitored start-up metrics to ensure all deliverables met quality standards and project timelines

Participated in kick-off and study setup meetings to identify data management risks and mitigation plans

Provided ongoing support for database amendments, ensuring proper testing and implementation post go-live

Led data cleaning and discrepancy management for multiple Phase II–III studies, achieving over 98% query resolution

Streamlined query review cycles by implementing prioritization metrics, improving turnaround time by 25%

Identified and resolved protocol deviations and visit date discrepancies between EDC and external source data

Monitored and maintained query aging reports and coordinated with site teams for timely resolution

Reduced query backlog by implementing weekly site query review dashboards

Automated recurring query detection through predefined logic

Oversaw external data reconciliation (Lab, ECG, Imaging, PK, SAE) with over 99% accuracy

Coordinated with vendors and data programmers to resolve mismatches and implemented a standardized reconciliation tracker

Reviewed and validated medical coding to ensure dictionary version alignment with protocol requirements

Maintained and updated Clean Patient Tracker with color-coded dashboards to monitor subject-level cleaning status

Acted as central contact for data management, clinical operations, medical coding, and biostatistics during review cycles

Conducted weekly data review and reconciliation meetings with sponsor teams

Proposed and implemented a standardized data cleaning workflow, reducing review time per subject by 15%

Contributed to edit check refinement post-UAT by identifying recurring data entry issues

Contributed to successful database go-live within agreed timelines and quality expectations

Improved database build cycle time through coordination with EDC and programming teams

Achieved 100% on-time database go-live by optimizing UAT and cross-functional coordination

Implemented process improvements that reduced build timelines by 15–20%

Ensured 100% subject clean status and coordinated cross-functional reviews before database lock

Conducted final data review and discrepancy checks to confirm data accuracy

Coordinated closure of all queries and documented completion of data management activities for audit readiness