At Salyx, I supported clinical trial documentation in line with FDA, Health Canada, and GCP guidelines. I maintained study folders and essential trial documents and managed lead tracking metrics in CTMS, improving document accessibility by 20%.
At Salyx, I also contributed to reducing site activation timelines by 15% through document coordination, tracking, and timely follow-up.
At the Bureau of Health Professions Licensure, I assessed compliance with FDA regulations and prepared regulatory reports and case files. I supported adverse event reporting and labeling reviews, and collaborated with regulatory teams on compliance cases.
Earlier, at Zydus Medical College and Hospital, I coordinated clinical research activities and led IRB submissions, Clinical Trial Applications, and CAPA processes. At Sumandeep Lifesciences LLP, I maintained trial data in REDCap and supported informed consent documentation, SOP development, and quality reviews.
