The Project Manager (PM) is an important member of the Alira Health Clinical team. * Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. * Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. * 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. * Supervises and provides support to the , 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.
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