04supriyagawai
About Candidate
Clinical Data Specialist: IQVIA Mar 2024 – Apr 2026
Identified the root cause of 50+ protocol deviations caused by site misunderstanding of form data entry
requirements; resolved the issue with a two-pronged corrective action: (1) proposed and implemented an
automated edit check to prevent incorrect data entry at source, and (2) developed and delivered a
dedicated site training presentation (PowerPoint) in a cross-functional meeting, walking sites through
expected data updates and correct form completion procedures — eliminating the entire manual query
backlog and preventing all further protocol deviations and sponsor escalations.
Spearheaded setup-phase activities for two oncology studies sponsored by Johnson & Johnson,
executing Test script creation and UAT, DRM data entry, JEISR configuration and form UAT — resulting in
successful, on-schedule go-live of both global studies.
Led the conduct phase with a focus on external Data Reconciliation, Query Discrepancy Resolution (QDR), PD
Review and CDISC-aligned data quality reviews to ensure ICH E6 GCP compliance and clean-data readiness
for database lock across multi-site global trials.
Served as primary study-level point of contact for global cross-functional teams, delivering weekly status
summaries, driving timely issue resolution, and maintaining consistent clean data delivery throughout the
full trial lifecycle with zero sponsor escalations.
Junior Data Analyst: Cognizant Technology solutions May 2021 – Mar 2024
Supported end-to-end CDM operations for 2 Phase II/III oncology studies and contributed to 3 additional
global trials for AbbVie, managing database lock activities, vendor reconciliation, and core CDM
deliverables in full compliance with ICH E6 GCP requirements.
Maintained data integrity across multiple study populations by executing automated and manual
reconciliation checks, proactively resolving discrepancies, and delivering clean, audit-ready datasets ahead of
all database lock milestones.
Prepared Clean Patient Tracker and HOS Reports on schedule throughout all project timelines,
supporting final database lock processes through effective cross-functional coordination and structured
quality control.
Mentored and onboarded junior CDM team members, developed role-specific training materials, and drove
continuous process improvements through systematic trend analysis and proactive issue resolution —
maintaining consistent performance across concurrent trials.
Location
Work & Experience
Identified the root cause of 50+ protocol deviations caused by site misunderstanding of form data entry requirements; resolved the issue with a two-pronged corrective action: (1) proposed and implemented an automated edit check to prevent incorrect data entry at source, and (2) developed and delivered a dedicated site training presentation (PowerPoint) in a cross-functional meeting, walking sites through expected data updates and correct form completion procedures — eliminating the entire manual query backlog and preventing all further protocol deviations and sponsor escalations. Spearheaded setup-phase activities for two oncology studies sponsored by Johnson & Johnson, executing Test script creation and UAT, DRM data entry, JEISR configuration and form UAT — resulting in successful, on-schedule go-live of both global studies. Led the conduct phase with a focus on external Data Reconciliation, Query Discrepancy Resolution (QDR), PD Review and CDISC-aligned data quality reviews to ensure ICH E6 GCP compliance and clean-data readiness for database lock across multi-site global trials. Served as primary study-level point of contact for global cross-functional teams, delivering weekly status summaries, driving timely issue resolution, and maintaining consistent clean data delivery throughout the full trial lifecycle with zero sponsor escalations.
Supported end-to-end CDM operations for 2 Phase II/III oncology studies and contributed to 3 additional global trials for AbbVie, managing database lock activities, vendor reconciliation, and core CDM deliverables in full compliance with ICH E6 GCP requirements. Maintained data integrity across multiple study populations by executing automated and manual reconciliation checks, proactively resolving discrepancies, and delivering clean, audit-ready datasets ahead of all database lock milestones. Prepared Clean Patient Tracker and HOS Reports on schedule throughout all project timelines, supporting final database lock processes through effective cross-functional coordination and structured quality control. Mentored and onboarded junior CDM team members, developed role-specific training materials, and drove continuous process improvements through systematic trend analysis and proactive issue resolution — maintaining consistent performance across concurrent trials.