Responsible for all aspects of Clinical Trials Management. Responsibilities include designing studies; selection and management of CRO’s and clinical trial sites; and scheduling, review, analysis and reporting of clinical trials. Provide leadership and staff management in the development and implementation of clinical protocols, data collections systems, adverse event reporting and preparation of reports. Primarily responsible for the design, implementation and interpretation of results of phase 2-3 clinical trials. Participate in preparation of IND’s, BLA’s, and other documents for submission to FDA and other regulatory agencies.
· Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices (GCP).
· Ensure compliance of clinical trials with national and international regulatory requirements.
· Interact with internal and external groups to facilitate clinical trials and achieve designated timelines.
· Lead and manage CRO relations for the selection, oversight and training of clinical investigators.
· Effectively manage clinical study budgets.
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