Mitraa N U

WORK HISTORY

EDUCATION

ABOUT MITRAA N U

Medical Writer with 4+ years of experience in handling clinical trial data. I have consistently demonstrated expertise in diverse facets of clinical research, ensuring the successful execution of trials and adherence to regulatory standards. Throughout my career, I have consistently upheld the highest ethical standards, maintained data confidentiality, and adhered to industry best practices. My proficiency in managing study timelines and resources has played a vital role in achieving project milestones and delivering quality results. I have successfully collaborated with cross-functional teams, fostering effective communication and synergy to overcome challenges and optimize trial processes. PROJECTS & ROLES Medical Writer • Primary focus on authoring Safety Narratives and Clinical Study Reports (CSRs). • Possess knowledge about ICH guidelines and skilfully apply it in my medical writing. • Demonstrating a strong commitment to accuracy and compliance, I have contributed to various clinical research projects. • Ability to assimilate complex clinical trial data, analyse the statistical results, and effectively present them in a clear and concise manner. • Have conducted and handled sponsor meetings like medical writing kickoff meetings, to clarify the comments/findings provided by the sponsors. • Understands customer requirements and comes up with solutions with adherence to the ICH guidelines. • Interacted with sponsor companies to discuss final report preparation and delivery and address the medical-legal review. Data Manager • Designing and implementing Data Management Plans. • Performed medical coding which has contributed to accurate and consistent reporting, ensuring the integrity of trial data. • Established quality in the clinical data by performing manual review, data reconciliation and query management to resolve data issues promptly. • Performed DM UAT for the programmed edit checks and offline checks UAT using SAS. • Experience in eTMF filing, indicating the ability to maintain well-organized and compliant trial documentation. • Performed Edit Check Quality Control (QC) for ensuring error-free and robust clinical trial databases. • Experience across a range of Electronic Data Capture (EDC) platforms - RAVE, Omnicomm TrialMaster, Viedoc, and IBM Clinical Development. • Demonstrate proficiency with the seeWISE tool, employed for the visualization of clinical data and the generation of comprehensive clinical reports.