This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process.
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.
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
Learning Objectives:
Describe project management as it applies to clinical research and in the management of clinical trials
Identify how project managers develop high performance project teams
Develop a project plan and work breakdown structure
Identify process mapping tools used in clinical research
Recognize the importance of effective project schedules
Identify clinical trial project budgetary needs
Identify performance metrics and utilize effectively to monitor project
Management of vendors within a clinical trial for optimal oversight and outcomes
Implement successful project closure and lessons learned
Areas Covered:
Prioritization and strategies in planning clinical studies
Recourses allocation
Outsourcing strategy
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