Darshan Chavan

Electronic Trial Master File ( eTMF)

• Manages the setup and maintainance of eTMF (Trial, Country, Site) for clinical studies in accordance with

eTMF.

• Proficient in using eTMF software and technologies to create, maintain, and archive clinical trial

documentation.

• Responsible for Mapping sponsor eTMF index.

• Maintain TMF in state of audit readiness for quality and compliance.

• Ensure metadata compliance.

• Processing documents into tmf system as per the guidance documentation and ensure quality and

productivity.

•Regulatory documents collection and distribution to sites throughout the trial.

• Collaborated with cross-functional teams, including clinical trial managers, data managers, and site staff, to

support effective trial management.

• To perform and review the TMF throughout the trial (study startup to study closeout).

• Identified and implemented process improvements to streamline eTMF management and improve

efficiency.

• Handling of critical documentation.

• working as Site Record Cordinator to provide documents to the sites diring trials

Software handling -Veeva vault and Birds and Wings.

• Trained new staff on document management systems and best practices.
• Reviewed documents for accuracy, completeness, and compliance with applicable regulations.

• Prepared and submitted dossiers in e-CTD format to global regulatory bodies (US FDA, EMA, MHRA, etc.) following ICH E3 guidelines.
• Reviewed and edited clinical documents: protocols, study reports, case report forms, informed consent forms.
• Worked closely with cross-functional teams to ensure timely and compliant document submissions.
• Conducted study closeout documentation and CDISC dataset checks as per regulatory requirements.

• Supported documentation throughout the clinical trial lifecycle, including protocol development, consent forms, and study tracking tools.
• Gained hands-on experience with document management processes and contributed to SOP development.
• Collaborated with teams to improve document sharing and compliance practices.