Primary duties/responsibilities: Performs as an integrated member of the clinical team to lead, direct and contribute to, the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting; recommends monitoring, safety, eligibility, enrollment, and data consistency strategies. Manages clinical study timelines using the appropriate project management tools; develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors; presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.