Project Management & the Business of Clinical Trials


Course Details

This course can only be taken as part of the Certificate in Clinical Trials.

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About this Course

Clinical trials involve a large number of tasks and people who are responsible for different parts of the overall study. The relationships among these parties require understanding and careful management to produce a successful study. Clinical trials have a business dimension that includes principles of project management, planning, analysis, contingency and follow-up.

Topics involving the management of clinical trials include:

  • Project management, budgets and timelines
  • Managing relationships among clinical trials constituencies (CRCs, CRAs, investigators, subjects, staff, IRBs, sponsors, etc.)
  • Management of people at work
  • Public relations and current topics

Topics involving the business of clinical trials include:

  • Public speaking and basic business skills such as personnel management and control of meetings
  • Overall investigational plan, including budgets and timelines
  • Quantifying business decisions and basic financial analysis tools
  • Site negotiations in single and multisite trials
  • Outsourcing and Contract Research Organizations (CROs)
  • The art of negotiations
  • Developing strategic partnerships
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