This course presents the effective planning and management of drugs and biologics clinical research trials. Exercises and case studies will illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic clinical development plans, team and clinical site performance problems are also discussed.

This course will benefit clinical research professionals who are planning to begin or like to manage clinical research studies.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe critical elements of a clinical trial projects, methods of project management and documentation
• Discuss role of a clinical trial manager and/or clinical project manager, and strategies of risk assessment and mitigation
• Discuss Clinical Trial Management Planning (Budgeting & Timeline)
• pathways and resources needed for successful clinical research trials, and tools of project management

Professional Credit

CA BRN/LVN Credit--Provider #CEP13114, 20.0 Hours.