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Tanvi Ghan

@tanvighan

I keep clinical studies audit-ready through precise regulatory documentation, IRB submissions, and cross-functional coordination.

United States

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What I'm looking for

I'm seeking a full-time Regulatory Affairs opportunity where I can support ethical, efficient, and compliant clinical research through audit-ready documentation and cross-functional coordination.

I've supported compliant clinical-study operations at Brigham and Women's Hospital, preparing staff readiness records, reconciling eISF documentation, and submitting IRB modification packages for PI transitions and protocol amendments.

At BIDMC and Harvard Medical School, I drafted IRB submissions and follow-up materials, audited study records across physical and electronic systems, and supported closeout through organized files, termination letters, and a records-management SOP.

Previously at Tata Consultancy Services supporting Boehringer Ingelheim, I managed eTMF documentation for 13–18 Phase I studies, met urgent-document timelines, trained associates, and helped reduce a document backlog by 83% in one month. I also led a post-market surveillance review of 300+ medical-device complaints, recommending EU MDR-, FDA-, and ISO 13485-aligned documentation updates.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Coordinator I

Brigham and Women's Hospital

Jun 2026 - Aug 2026 (2 months)

Ensured staff compliance during study initiation by preparing DOA and training logs, verifying credentials, and coordinating system access. Improved eISF quality by reconciling essential documents in Veeva Vault and Florence eBinders, and supported PI transitions and protocol amendments by preparing IRB modification packages.

Veeva Vault Florence EBinders IRB Submission WCG Advarra Salus Alpha IRB Doa FDA 1572 Informed Consent Forms Regulatory Documentation

Regulatory Affairs Intern

BIDMC / Harvard Medical School

Feb 2026 - May 2026 (3 months)

Supported regulatory management for active and closed clinical studies by drafting IRB submissions, amendments, and follow-up materials. Audited physical and electronic binders, SharePoint folders, and tracking logs, and supported study closeout by organizing files and developing an SOP.

IRB Submission IREX REDCap CTPro SharePoint GCP ICH SOP Development Records Management

Quality Checker

Tata Consultancy Services

Oct 2020 - May 2023 (2 years 7 months)

Managed eTMF documentation for 13-18 Phase I studies, collaborating with CRAs, CTLs, CTMs, and PIs to create placeholders and reconcile records. Trained 4-5 associates across seven cohorts, supported CAPA and root-cause analysis, and reduced document backlog by 83% in one month.