Program Description

Clinical Research Project/Program Management Conference

Goal: Clinical trial project and program management incorporate a broad range of skill sets in order to plan, administer, track, evaluate and report activities and budgets involved in clinical trials. The goal of this program is to introduce, affirm or enhance the participant’s understanding of the project management endeavor.

Objective: Through discussion, presentation, and interaction, this program will broaden the participants’ knowledge of the regulatory framework, project management art and science, planning and accounting, and their attitude and aptitude for achieving successful clinical trials.

Learning Objectives: Upon completion of the program, the attendee should be able to:

  • Discuss the project management processes: (Initiation, Planning, Execution, Monitoring, Controlling, and Closing) as well as strategic and operational planning.
  • Discuss the principles of project management following Project Management Institute (PMI) including a brief history of PMI, key terms, the project life cycle, and knowledge areas.
  • Discuss the project management principles following PMI (Project Management Institute) guidelines as well as project management knowledge areas and process group mapping.
  • Discuss developing and maintaining project management tools and techniques for project planning and assessment of progress.
  • Discuss the basic principles of risk management, risk avoidance, and risk mitigation.
  • Discuss budget development and financial management topics including: general start up issues, study feasibility, potential pitfalls in budgeting, and strategies to manage impasses and identify hidden costs.  
  • Discuss the contract review process and the importance of successful interactions between sponsors, CROs and sites when negotiating Clinical Trial Agreements
  • Discuss strategies to recognize and resolve conflict proactively and to promote effective team building as well as mental health.