This course examines the concepts and applied techniques for cost estimation, risk management and quality assurance for clinical research projects. Project management principles and methodology are provided with special focus on planning, controlling, and coordinating individual and group efforts. Key topics include overview of modern project management in clinical trials, organization strategy and project selection, defining a project and developing a project plan and scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks through lectures, case studies and discussions will provide a significant competitive advantage in the marketplace for clinical research professionals.
Prioritization and strategies in planning clinical studies
Assigning role and responsibilities of study team members
Cost estimation and budgets for clinical project
Establishing schedules, timelines to meet corporate goals
Risk Management and Quality Assurance strategies
Who Should Attend:
New Project Managers, Project Managers with little or no drug development or clinical trial experience, Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials, New Clinical or other Project Team Leaders who will be managing projects, Managers unfamiliar with clinical project management, New Clinical, Regulatory, and Department Staff who will design clinical trial programs, Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management, Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers, Grant Administrators