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. * Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. * Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. The Sr. Project Manager is an important member of the Alira Health Clinical team. The SCPM ensures the efficient implementation of study protocols, works closely with all , and communicates directly with study sponsors and vendors. * Serves as study lead and primary contact for . * Generates and presents frequent study status updates and reports to sponsor.
mehr