The Medical Monitor at Ocugen Opco Inc. plays a crucial role in providing unbiased, 24/7 medical guidance to investigators, clinical sites, and study operations teams for various products in clinical stages. This position is responsible for ensuring that all medical aspects of clinical trials are conducted in compliance with protocols and regulatory requirements. The Medical Monitor will provide therapeutic and compound training, offer medical guidance on protocol compliance, and assist in the coding of medical terms. Additionally, the role supports clinical safety and data management by reviewing data listings and may contribute to the writing of the final study report. Regular communication with the medical team, including medical teleconferences, is essential, as well as interfacing with sponsor medical groups throughout the studies. The Medical Monitor will clarify general protocol questions and provide medical guidance as required. They will answer medical safety and protocol questions directly from sites or through the Site Manager, respond to specific inclusion/exclusion criteria questions, and address safety inquiries from the site or local IRB/IEC. Participation in locally held investigator meetings is expected, along with interaction with Key Opinion Leaders (KOLs) for local advisory board support. The role also involves performing local adverse event reviews prior to DSMB reviews, assessing causality on all serious adverse events (SAEs) at a regional level, and following up with investigators for additional information or clarifications. Moreover, the Medical Monitor will write country or site-specific Informed Consent Forms (ICFs), provide input on site selection and country feasibility, and consult with Medical Directors and Sponsor Medical groups regarding medical questions related to the study indication. They will quickly identify safety issues, consult on unblinding trial participants, review laboratory values, and recommend protocol changes as necessary. The position requires participation in the development, review, and finalization of protocols, amendments, and Clinical Study Reports, as well as providing medical input into data collection tools and study plans. The Medical Monitor will also attend and lead medical monitoring teleconferences throughout the study as required.