Aachal Satpute

About Aachal Satpute

With over 6 years of experience in eTMF and drug safety, I specialize in enhancing Clinical research industry through meticulous oversight of electronic Trial Master Files (eTMF) and regulatory compliance. At KlinEra Global Services, I ensure audit-ready documentation, manage eTMF processes, and maintain high-quality standards in study documentation. My role involves optimizing eTMF processes to support global study documentation, data analysis, and regulatory submissions, which contributes to the seamless execution of clinical trials and strengthens brand credibility in the industry.

Experience

1. Senior Process Associate (Document Reviewer)

   Tata Consultancy Services

   Feb 2025 — Present · Mumbai, IN

   Collected, reviewed, maintained, and archived essential TMF documents as per GCP and regulatory guidelines.• Processed documents according to TMF index and study-specific plans.• Supported TMF content owners and study teams to ensure inspection readiness in Veeva Vault.• Performed completeness checks, technical QC, and metadata validation in Veeva.• Prepared and shared study-specific monthly reports with clients.• Tracked TMF performance metrics and reported results within defined timelines.• Ensured daily task completion with high quality and productivity standards.• Trained and mentored new team members and supported team lead in task allocation.

Education

• University of Mumbai

  Bachelor's degree