Arjun Anthony

• Led global TMF teams across India and the U.S., ensuring inspection readiness and document quality compliance.

• Oversaw eTMF setup, configuration, and process optimization using WingSpan and Veeva Vault.

• Conducted TMF audits, trainings, and acted as SME for global sponsor studies.

• Managed TMF KPIs, audit tracking, and document quality metrics for continuous improvement.

• Collaborated with Regulatory, Clinical, and QA teams to maintain end-to-end documentation accuracy.

TECHNOLOGIES

Veeva Vault, WingSpan, eTMF Analytics, CTMS, MS Excel Dashboards, Audit Tracker

• Managed end-to-end site file documentation from SIV to study close-out.

• Performed quality control checks for audit readiness and ensured compliance with sponsor and ICH-GCP standards.

• Supported transition calls and document reconciliations between SSU and File Maintenance teams.

• Assisted multiple global Phase III studies using WingSpan and NextDoc systems.

TECHNOLOGIES

WingSpan, NextDoc, CTMS, MS SharePoint, Excel-based Quality Dashboards

• Supported eTMF setup and quality review across multiple global clinical studies.

• Maintained document inventories and ensured regulatory filing compliance per 21 CFR Part 11.

• Conducted TMF quality audits and provided training to new team members.

• Coordinated with global teams for document exchange and archival activities

TECHNOLOGIES

Veeva Vault, ICOMaster, FirstDoc, WingSpan, MS Office, eTMF Quality Audit Tool

• Performed internal site monitoring and QA/QC for active clinical trials.

• Managed CRA training, academic programs, and internship coordination.

• Delivered lectures in Clinical Research, Pharmacovigilance, and Regulatory Affairs.

TECHNOLOGIES

CTMS, Excel Site Tracker, Regulatory Document Templates, MS Teams