Associate Director Clinical Operations
Managed several clinical studies. Leveraged operational expertise to establish study level strategies to align with the Clinical Development Plan (CDP). Developed and maintained SOP’s, clinical budgets, Clinical Quality Systems, Clinical Study Reports, and Investigator Brochures. Monitored all aspects of clinical trial conduct including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial. Prepared and reviewed clinical sections of required regulatory documents, including briefing documents, Investigational New Drug (IND) filings, Clinical Trial Applications, safety reports, final study reports. Supported the design and execution of quality management plans consistent with GCP and other applicable government and regulatory agency standards.
