Responsible for ensuring the timely, efficient and effective execution of clinical studies that will meet all regulatory requirements for product approvals. Responsible for the management of the clinical studies in accordance with the applicable domestic and international government regulations, Investigational Plans (IP), and Standard Operating Procedures. Assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for multiple new projects to ensure successful product development and worldwide marketing efforts.
Included in the management of each study are study design, protocol development, and coordinating, managing and working with clinical support resources such as a clinical research monitors, Field Clinical Engineers, and Clinical Research Associates. Provide clinical support to Sales and Marketing Departments as required. Work closely with Clinical Management to recommend and implement improved methods by developing and/or modifying department procedures, systems, and in-house training that ensure compliance with regulatory requirements.