Shubhangi Shinde

I am a CCDM®-certified Clinical Data Associate with 4+ years supporting global Phase I–IV trials across oncology, neuroscience, ophthalmology and respiratory disorders. I specialize in end-to-end data management from study startup through database lock, ensuring adherence to ICH-GCP, 21 CFR part 11, GDP and internal SOPs.

I have hands-on expertise with Medidata RAVE, Veeva Vault, DIVA and related CDMS tools, and routinely perform discrepancy management, vendor reconciliation, SAS/programmed listing review, safety dataset review and study-specific metrics preparation. I have led and mentored CDM teams, managed change control, and supported UAT and edit-check validation.

My track record includes maintaining Data Issue Logs, performing lab/biomarker/PK/SAE reconciliations, RECIST and adjudication reviews, and preparing CPT and metric documentation to meet study timelines. I collaborate closely with sponsors, vendors, programmers, statisticians, QA and project managers to enable smooth database locks and high-quality data deliverables.

I am pursuing an MBA (Healthcare Management) and bring a practical, quality-first approach to data interpretation and reporting to support informed decision-making and timely, compliant study delivery.