Smruti Mankame

Experienced Associate Manager in Trial Master File (TMF) operations with a solid background in clinical research, document management, and training. Proficient in overseeing TMF processes to ensure compliance with regulatory requirements and company standards. Skilled in implementing and maintaining TMF systems, managing electronic and paper-based documentation, and coordinating with cross-functional teams to support clinical trials. Demonstrated ability to lead projects, mentor team members, and enhance operational efficiency. Formerly a Training Manager responsible for India and global departmental training for new joiners. Successfully wrote and updated training materials in line with new SOP releases, process enhancements, and changes in regulations. Seeking challenging opportunities to further enhance expertise and develop a career in leadership. Committed to maintaining high-quality standards and contributing to the success of clinical research initiatives.

11 Years 0 Month

• Site File Associate, Site File Operations, IQVIA, Responsible for managing site-level documents for assigned studies, including the meticulous review of site-level documents and ensuring accurate document uploading in accordance with filing standards for both Wingspan and Customer eTMF systems., Conducted periodic file reviews to ensure all expected documents were filed accurately and complied with regulatory requirements., Periodic TMF reviews to identify missing documents & ensure required documents are filed & maintained accurately., Managing action items and query resolutions with project teams, ensuring timely and effective communication., Performing monthly follow-ups with Clinical Research Associates (CRAs) and other study team members to ensure prompt closure of action items., Implementing and maintaining a systematic approach to document management, contributing to the smooth operation and success of clinical studies.
• Short Term Annual Biotechnology Training, Haffkine Institute for Training, Research and Testing

Travelling, Dance, Learning new skills