Responsible for managing clinical trials from initiation to completion through leading or participating in the development of study protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives.
Duties: Responsible for the design and implementation of pre-market and post-market clinical trials. Develop and manage the project plan including a budget and timeline. lead the development and finalization of study protocols by coordinating input from various sources including literature, experts, and internal team members. Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories. Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective. Ensure monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective. Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. Manage the clinical study report as well as the clinical portion of regulatory submissions. Participate in the preparation of scientific abstracts and manuscripts. Supervise 4 subordinate employees.