Open to opportunities

Shubhangi SHINDE

@shubhangishinde1

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CCDM®-certified clinical data associate driving accurate, compliant trial data.

India

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What I'm looking for

I seek a collaborative clinical data role where I can lead data quality, mentor teammates, work with cross-functional stakeholders, and contribute to timely database lock and accurate trial reporting.

I am a CCDM®-certified Clinical Data Associate with over 4 years supporting global Phase I–IV trials across oncology, neuroscience, ophthalmology and respiratory disorders, delivering clean, high-quality data on time while adhering to ICH-GCP, 21 CFR part 11, GDP and internal SOPs.

I have hands-on expertise in Medidata RAVE, Veeva Vault, DIVA, Clinical INK and related CDMS tools, and I led discrepancy management, vendor reconciliation, SAS/programmed listing review, safety dataset review and study-specific metrics to support timely database lock and sponsor reporting.

I collaborate closely with sponsors, vendors, programmers, statisticians, QA and project teams, mentor junior colleagues, and aim to leverage my data management and interpretation skills to improve decision-making and ensure the highest level of accuracy in clinical data reporting.

Experience

Work history, roles, and key accomplishments

Current

Clinical Data Associate

Current

Eli Lilly and Company

Nov 2024 - Present (11 months)

Working on neuroscience trials performing discrepancy management, DIVA checks, page review, vendor reconciliation and SAS/programmed listing review to deliver clean data within timelines and compliance.

Diva Vendor Reconciliation SAS Data Cleaning ICH GCP

Clinical Data Analyst II

Fortrea

Nov 2022 - Nov 2024 (2 years)

Led and mentored CDM tasks across 3+ studies including discrepancy management, RECIST review, UAT and SAS listing/programmed listing reviews, driving consistent on-time deliverables.

Diva Clinical INK RECIST SAS UAT Vendor Reconciliation

Clinical Data Analyst

CBCC Global Research

Jul 2021 - Oct 2022 (1 year 3 months)

Planned and performed daily CDM activities (QDR/manual review/SAS listings), prepared study metrics and CPT reports, and managed vendor reconciliations to support database lock activities.

SAS Vendor Reconciliation Metrics And Reporting Database Lock