Open to opportunities

Shraddha Nade

@shraddhanade

eTMF document specialist improving clinical trial document quality, reconciliation, and quality control for compliant submissions.

India

Message

What I'm looking for

I’m looking for a strong opportunity in corporate clinical research services where I can deliver error-free eTMF document QC, support study start-up and close-out, and ensure compliant regulatory/IRB documentation with ICH-GCP and 21 CFR Part 11.

I help keep eTMF/TMF content high-quality and submission-ready. I supported a Novartis project by performing import and quality check (QC) activities and working across eTMF tools like eTMF subway, CREDI, Veeva Volt, and Trial Interactive (TI).

With experience at Atos Syntel Pvt Ltd as an associate GCM level 2 (eTMF Qcier) and currently as an eTMF Doc Specialist in CDM (Record Management), I identify essential documents, reconcile and correct them, and process QC imports of regulatory and IRB documents. I follow ICH-GCP and 21 CFR Part 11, manage study startup/close-out, maintain filing structure and metadata standards, and support archival for sponsor audits and regulatory inspections—while handling priorities to meet client requirements.

Experience

Work history, roles, and key accomplishments

Current

eTMF Doc Specialist

Current

Precision for Medicine Pvt Ltd

Oct 2023 - Present (2 years 9 months)

eTMF Doc Specialist in the eTMF domain within CDM (record management), managing study documentation activities. Received Awardco recognition for study-specific task completions and collaborations.

ETMF CDM ICH GCP Docusign Signpost MS Excel MS Word PowerPoint MS Access

Associate GCM Level 2

Atos Syntel Pvt Ltd

Mar 2021 - Oct 2023 (2 years 7 months)

Associate GCM Level 2 (eTMF Qcier) in CDM, performing eTMF quality control, document reconciliation, and importing regulatory/IRB documents for clinical trials. Supported study start-up/close-out, discrepancy handling, eTMF archival for audits, and received team and performance awards.