Introduction to Managing Clinical Trials
Overview
This course is designed for pharmaceutical and biotech professionals responsible for overseeing and managing clinical trials. It will teach the essentials of project management, with a focus on how these skills can be applied to the product development process and day-to-day management of clinical trials. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different organizational styles, the need for financial analysis, skills for planning and management, team building, and other key topics.
Who will benefit
This course will be beneficial to those new to managing clinical trials, as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers not versed in project management as well as clinical and drug development staff involved with clinical trial programs will also benefit.
Key topics
- The project life cycle
- The importance of planning
- Building an effective team
- Managing risk
- Effective communication
- Financial management
- Management of client/vendor relationships
Learning outcomes
- Describe project management in the context of the product development process.
- Define the project lifecycle and the relationship between time, cost and quality/technical objectives.
- List the general responsibilities, knowledge, skills, and tools used by project managers.
- Use a project management plan or team charter to provide structure.
- Describe risk management and how to assess project risks.
- Develop a work breakdown structure: tasks, deliverables and timelines.
- Build a budget process that helps manage cost.
- List the main elements in monitoring and controlling a project.
- Identify effective tools and metrics to measure project progress and performance.
- Describe how planned communication enhances project management.
- Illustrate how to create and manage a good team.
Learn more about bringing this course in-house.
