Oversee study- and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate, and complete. * Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Study Management Plans, Case Report Forms (CRFs), and support the creation and maintenance of full clinical study documentation. * Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical product management, and clinical supplier management. * Conduct site management & monitoring, clinical product management, and clinical field support activities/visits, as needed.
mehr