In this course I will explain the rationale and methodology for managing the subject enrollment in the clinical trials. Starting with the key elements and process of the project management, I will elaborate in detail from identifying the business needs, through the regulatory requirements, to the steps of the clinical trial managements for subject enrollment, including the site feasibility, selection, start-up, and issue management. The tools for monitoring the trial status will be introduced to the learners, as well the risk registry used for risk management, including the Gant Chart, the milestone tracking, the monitoring by making the enrollment curve based on the bottom-up method of collecting the site-based information.