Snehal Parate

Dedicated eTMF Specialist with 4+ years of experience in electronic Trial Master File management across Phase I–IV clinical studies. Expert in audit-ready TMF maintenance, ICH-GCP/GDP compliance, and regulatory inspection preparation, with a track record of zero major audit findings across concurrent global trials. Proven ability to perform TMF quality reviews, track document completeness against TMF Plans and Indexes, identify and resolve operational issues, and drive continuous improvement initiatives.

Experienced in direct cross-functional study team coordination, and proactive management of corrective actions.

Associate TMF Specialist - Emmes Group India

(2024-09)

• Managed eTMF (Trial, Country, and Site artifacts) for 20+ concurrent Phase I–IV global clinical studies using Veeva Vault TMF, ensuring full compliance with ICH-GCP, GDP, TMF Reference Model, and sponsor SOPs.
• Performed Audit Ready Checks on every document uploaded in the eTMF system, validating context accuracy, metadata, and version control to maintain continuous inspection readiness.
• Initiated and tracked 'What's Missing' reviews for all studies, identifying and following up on missing, incomplete, or inaccurate artifacts against TMF Plans, Indexes, and study milestones to ensure full completeness.
• Conducted TMF quality reviews as a TMF Reviewer, evaluating documents for accuracy and compliance; contributed to TMF completeness improvements of 15–20% per study.
• Mapped sponsor TMF Index structures and reconciled against internal TMF processes, supporting alignment across cross-functional study teams and external sponsors.
• Prepared TMFs for QA and sponsor audits; identified and implemented corrective actions in response to audit findings, achieving zero outstanding findings.
• Gathered and compiled TMF status data requested by study teams to support client status reports, attending internal and external study team meetings as required.
• Reviewed and responded to TMF content quality issues, identifying trends per study and across programs, and escalating patterns to management for process improvement.
• Coordinated document collection across 3+ study teams and vendors, resolving discrepancies and improving retrieval timelines by 25%.
• Participated in business improvement initiatives, contributing to process standardization that improved operational efficiency by 20%+.

Clinical Research Coordinator - QRed Clinical Research Services

(2021-10 - 2024-08)

• Led clinical operations and subject recruitment across 6 concurrent trials (oncology, respiratory, dermatology), managing 150+ participants across 10+ sites from enrollment to close-out
• Managed Investigator TMF (2000+ documents) for global studies, ensuring 100% audit readiness and compliance with ICH-GCP and FDA regulations
• Monitored site performance and compliance, executing corrective actions (remote + on-site), achieving 100% timely issue resolution across all sites
• Reviewed and validated data for 150+ participants across 6 trials, ensuring data accuracy and completeness for regulatory submissions
• Collaborated with CRAs, CTAs, and centralized monitoring teams, strengthening cross-functional communication and improving study execution efficiency

MSc - Biotechnology - RTMNU, Nagpur

BSc - Biotechnology - RTMNU, Nagpur