• Direct input into the clinical operational strategy and plans. • Implementation and management of the clinical operational plans and programs to meet corporate goals and objectives. • Work with Clinical Development to draft clinical trial protocols and other trial-related documents, and work with other departments and functions to implement clinical trial protocols. • Serve as an interface with clinical investigators. • Effectively negotiate contracts with consultants, clinical investigators, and contract research organizations. • Conduct funding negotiations with clinical sites when necessary. • Support the management of site-related activities, development of tracking tools, and manage recruitment timelines. • Prepare updates on study progress. • Prepare the study budgets, and track payment of contracts related to the project. • Generate clinical department SOPs and conduct trainings as necessary. • Regularly make presentations to senior staff members and participate in relevant Development Team meetings. • Procure and oversee outside vendors and consultants as required. • Supervise and manage activities of clinical operations personnel. • Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials. • Attend scientific and external training meetings as needed. • Other clinical operations activities as required.