Sonia Chataule

About Sonia Chataule

Clinical research professional with 6+ years of experience in pharma, site coordination, and global CRO settings. Specializing in TMF compliance, clinical operations, and cross-functional teamwork for oncology and other studies. Passionate about quality, collaboration, and driving process excellence in clinical research.

Experience

1. Tmf Lead (Sponsor-dedicated)

   Tata Consultancy Services

   Mar 2023 — Present · IN

   TMF Management: Overseeing the organization, maintenance, and completeness of the Trial Master File throughout the clinical trial lifecycle.• Documentation Oversight: Ensuring all essential documents are collected, reviewed, and filed correctly in accordance with regulatory requirements and company SOPs (Standard Operating Procedures).• Quality Control: Conducting quality checks on TMF documents to ensure accuracy, completeness, and compliance with regulatory guidelines.• Training and Guidance: Providing training and guidance to team members on TMF requirements, document management processes, and best practices.• Process Improvement: Identifying areas for process improvement related to TMF management and implementing solutions to enhance efficiency and compliance.• Collaboration: Working closely with cross-functional teams including Clinical Operations, regulatory affairs, Quality Assurance, and Data Management to ensure alignment on TMF requirements and deliverables.• Risk Management: Identifying and mitigating risks associated with TMF management to ensure data integrity and regulatory compliance.• Vendor Management: Overseeing TMF activities performed by vendors or external partners, ensuring adherence to contractual obligations and quality standards.• Documentation of TMF Metrics: Tracking and reporting TMF metrics such as completeness, timeliness, and quality to Clinical Trial Lead, Clinical Trial Managers and Management Team. Accountable for TMF Health and managing and leading trial-level TMF activities. Ensure all country intelligence and trial-specific expected documents are applied (add/remove EDs) in veeva

Education

• Guru Nanak Khalsa College, Matunga, Mumbai (Autonomous)

  Master of Science

  2015 — 2017

• Elphinstone College

  Bachelor of Science - BSc

  2012 — 2015

• Kendriya Vidyalaya

  Hsc

  2011 — 2012