• 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 • Supervises and trains Associate PMs • 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 • Ensures accuracy of reports and material work product • Provides monthly billing information to finance team • Presents at project meetings such as investigator meetings and new client meetings • Updates management accurately and regularly through frequent communication • Identifies issues and develops problem-solving strategies to ensure study timelines are met • Manages subject accrual, retention, and compliance • Assists in TMF management and manages TMF reviews as needed • Prepares for and participates in third-party audits and FDA inspections • Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs • Participates in internal, client/sponsor, scientific, and other meetings as required • Performs additional duties as assigned.