As an experienced clinical research professional with over a decade of expertise in various functional roles, including data management, records management, and regulatory publishing, I am determined and outcome-driven, always seeking to enhance my skills to align with customer interests. My expertise in DCF drafting, verification, and CRF entry has helped me in successfully managing trial master file (TMF) documents for clinical trials in compliance with GCP guidelines and regulatory requirements.Currently working as a TMF Specialist at IQVIA, Thane, Maharashtra, I develop and implement TMF processes and SOPs while conducting quality control and review to ensure the accuracy, completeness, and accessibility of trial documentation. I coordinate with cross-functional teams such as clinical operations, data management, and regulatory affairs to ensure timely and accurate filing of essential documents. In addition to maintaining TMF plans and tracking document status, I provide training and support to study teams on TMF processes and best practices. Furthermore, I participate in TMF-related audits and inspections, act as an SME for the file management process, and support mentor/training to coworkers within RIM.During my tenure at Syntel Ltd, Pune, Maharashtra, as a Sr. Clinical Process Associate, I performed QC and importing of the essential/clinical documents in the repository center with respect to the filing location through eTMF tool. I conducted reviews of documents with compliance to GCP and SOPs, met month-end reporting objectives and deadlines, and participated in special projects to increase productivity and make a meaningful impact on company and mission. Additionally, I performed reconciliations to drive accuracy and validity of financial information and quality assurance checks on transactions and account actions to assess compliance with GCP regulations.In conclusion, my expertise in clinical research and data/records management, coupled with my ability to manage TMF documents for clinical trials in compliance with GCP guidelines and regulatory requirements, would make me an asset to any organization.