Aditi K.
Etmf Documentation Specialist (Document Reviewer) @Tata Consultancy Services
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WORK HISTORY
Etmf Documentation Specialist (Document Reviewer) @Tata Consultancy Services
Document Reviewer-Managing eTMF for clinical studies in accordance with TMF process, working with key study personnel such as CTM, CTL and study team members-Responsible for performing TMF Review. TMF reviewers may include, but are not limited to Project team members, members of Global Quality Control and other reviewers-Process, control, coordination, and approval of clinical trials documents-Maintaining an understanding of applicable regulatory requirements-Process and track final essential documents throughout all phases of study in accordance with SOPs, GCP and ICH guidelines-Manages identification of operational issues and resolution and initiating what\'s missing for all documents and ensuring all completeness in TMF of each study-Tracking and obtaining missing, incomplete, incorrect, inaccurate documents against the TMF plan and index andstudy milestone-Maintaining TMF in state of audit readiness for quality and compliance by performing audit ready checks on individual documents uploaded in eTMF for every study,ensuring context is accurate.
EDUCATION
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, Pharmacy
Element Health Suite (Elenity Clique LLP)
Training of medical coding and Certified Professional Coder Course, Medical coder
MITCON INSTITUTE OF MANAGEMENT
Post graduation diploma in clinical research and management , Clinical/Medical Laboratory Science/Research and Allied Professions
ABOUT ADITI K.
R & D eTMF Document Specialist || Sanofian || Ex-TCSer || Clinical Operations || Veeva Vault || Clinical Trials Management System ||
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