Amol Pandit

About Amol Pandit

I am an accomplished eTMF and Clinical Operations professional with over 3 years of experience in managing and optimizing electronic Trial Master Files (eTMFs) for global clinical studies. My background in Pharmacy (Diploma, Bachelor’s & Master’s) combined with a Postgraduate Diploma in Clinical Research & Pharmacovigilance enables me to bridge scientific knowledge with regulatory excellence and documentation precision- Core Expertise• eTMF management, quality control, and reconciliation using Veeva Vault, TMF Crosslink, and Trial Interactive• Maintaining inspection readiness, compliance, and data integrity throughout the clinical trial lifecycle• Deep understanding of ICH-GCP, TMF Reference Model, and global regulatory documentation standards• Strong collaboration with CRAs, CTAs, Data Management, and Regulatory Affairs to ensure seamless trial documentation-Key Achievements• Over 3 years of hands-on experience supporting end-to-end clinical trial documentation and operations• Consistently maintained 100% audit-ready eTMFs with zero critical findings during sponsor and QA inspections• Improved TMF QC turnaround time by streamlining workflows and implementing proactive quality checksI am passionate about advancing clinical research through accurate, compliant, and inspection-ready documentation systems that support regulatory excellence and operational efficiency.

Experience

1. Etmf Process Associate

   Tata Consultancy Services

   Oct 2024 — Present · Pune District, IN

   Processed and maintained 2,500+ TMF documents per month with 98% accuracy, ensuring compliance with SOPs, RIM workflows, and ICH-GCP standards. Managed end-to-end document lifecycle including upload, metadata validation, approvals, corrections, and rejections in accordance with clinical trial documentation standards. Improved crosslink accuracy and metadata consistency across parent and supporting documents, reducing rejection and clarification rates by 15%. Resolved 95% of CRA/CTA queries within defined SLA timelines through the BSC ticketing system, maintaining seamless communication and issue resolution. Conducted weekly Quality Control (QC) reviews and implemented corrective and preventive actions (CAPA), boosting audit readiness scores and inspection compliance. Collaborated with Quality Assurance, Compliance, and Project Management teams to streamline TMF workflows and enhance regulatory documentation efficiency. Delivered comprehensive training and cross-training sessions to 12+ associates, cutting onboarding time by 50% and improving team productivity. Monitored document metrics, KPIs, and compliance trackers to ensure adherence to SOPs, TMF Plan, and global regulatory requirements. Supported TMF audit and inspection readiness by ensuring timely filing, version control, and data integrity across study documentation.

Education

• BridgeSang Trainings And Consultancy

  Postgraduate Degree

• AISSMS College of Pharmacy - India

  Bachelor of Pharmacy , Pharmacy

• KYDSCT's College of Pharmacy, Sakegaon, Jalgaon

  Master of Pharmacy, Pharmaceutics and Drug Design

• MBES College of Pharmacy, Latur

  Diploma In Pharmacy, Pharmacy