Director, Clinical Operations

Provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring) across countries. This role ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations. The Director collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels. Essential functions include developing corporate and departmental business strategies, implementing regional clinical operations strategies, and leading operational staff. Ensures Clinical Operations personnel meet quality standards and regulatory requirements, interacting with Project Managers to resolve study issues. Identifies impacts to project scope, resources, schedule or budget through standard methods. This position requires in-depth experience in pharmaceutical and/or device research and travel domestically and internationally.