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

C
Clinical data specialist 03/2024 - 04/2026
IQVIA

 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.

J
Junior data analyst 05/2021 - 03/2024
Cognizant technology solutions

 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.