Brijesh Rathore

About Brijesh Rathore

Experience with eTMF(Veeva, Trial Interactive) EDC, CTMS, study start up, regulatory documentation. Trained in ICH GCP Guidelines. Experience in drugs and medical devices class II and in Microsoft Excel, Word,Adobe, Google Suite, Smartsheets, Box and OneDrive. Passionate. Looking for eTMF/TMF specialist,Clinical Records Specialist, Documentation Specialist roles.

Experience

1. Sr Clinical Trials Associate

   Mirum Pharmaceuticals, Inc.

   Nov 2025 — Present · South San Francisco, CA, US

   Management and oversight of TMFs within Veeva Vault eTMF, ensuring accurate filing, indexing, and metadata quality throughout the study lifecycle- Partnered closely with Project Leads, Study Teams, and CROs to maintain inspection readiness and TMF compliance across multiple clinical trials- Supported study start-up and close-out activities, including development and execution of TMF Plans, TMF Oversight Plans, Expected Document Lists (EDLs), and TMF archival or transfer activities- Monitored TMF health using Veeva Vault reports, dashboards- Generated and delivered routine TMF status, completeness, and quality reports; drove timely remediation activities with cross-functional teams and CRO partners- Conducted ongoing TMF quality control and oversight reviews to ensure alignment with internal SOPs, ICH-GCP requirements, and DIA TMF Reference Model standards- Oversee CRO and internal teams in the preparation, handling, filing, distribution, and archiving of essential clinical documents in compliance with established procedures- Managed Veeva Vault TMF user access, roles- Planned, executed, and documented TMF inspection readiness reviews, supporting internal audits, sponsor audits, and health authority inspections- Provided direct TMF audit and inspection support, including document retrieval, issue tracking, and corrective action follow-up- Maintained up-to-date knowledge of SOPs, ICH-GCP, regulatory expectations, and evolving TMF inspection trends- Participates in departmental & study meetings to communicate TMF health, risks, and readiness status- Distributing meeting agendas and meeting minutes- Organizing & planning of meetings (e.g. agendas, minutes, rooms, participants)- Maintains study training matrix- Familiarity with Compliance Wire- Experience with Veeva Quality Docs, Veeva Clinical, Veeva Promomats- Regulatory Compliance packet reviews- Creating and managing trackers and logs for oversight of clinical trials- Updates CT.gov

Education

• Udemy

  Basics of Clinical Data Management

  2021

• Guru Nanak Dev University

  Bachelor of Science, Biology

  1996 — 1998

• CCRPS

  Advanced Clinical Trial Assistant certification

• Makhanlal Chaturvedi National University of Journalism and Communication, Bhopal

  Post Graduate Diploma in Computer Applications, Computer Science

  1998 — 1999

Skills

• Technical Recruiting
• Business Development
• Project Management
• Screening
• Business Analysis
• Relationship Management
• Hris
• Mis
• Employee Engagement
• Performance Management
• Performance Appraisal
• Recruiting
• Banking
• Team Management
• Talent Acquisition
• Talent Management
• Retail Banking