• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines. • Serves as study lead and primary contact for sponsors. • Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. • Generates and presents frequent study status updates and reports to sponsor. • Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. • Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. • Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. • Identifies issues and develops problem-solving strategies to ensure study timelines are met. • Prepares for and participates in third-party audits and FDA inspections.