Halloran - For Your Development

Managing Clinical Trials - Advanced

Overview

This course is designed for pharmaceutical and biotech professionals responsible for managing clinical trials and programs. It will explore some of the more challenging issues of project management and assumes that attendees have some prior knowledge in this area. Through the use of lectures, discussions and hands-on workshops, the instructor will teach about different approaches for maximizing the efficiency at which clinical programs are run while at the same time minimizing risk.

Who will benefit

This course will be beneficial to clinical project managers who have an understanding of project management basics as well as those with project management experience but limited exposure to the pharmaceutical or biotech industries. Managers with a fundamental understanding of project management as well as clinical and drug development staff involved with clinical trials programs will also benefit.

Key topics

  • Achievement of corporate goals
  • Effective communication
  • Design of clinical trials
  • Project management resourcing
  • Global trials
  • Managing an effective team: roles & responsibilities, delegating, and managing up
  • Risk management: identification, assessment, mitigation, action plans
  • Project monitoring and control
  • Process improvement

Learning outcomes

  • Understand the impact of strategic decision-making in project management
  • Describe various trial designs and the rationale for selection
  • Effectively manage project risks: identify, assess, plan controls, track, and monitor.
  • Describe the importance of resource planning to project success.
  • List strategies for improving site selection and patient recruitment.
  • Select the best measures of project progress and performance.
  • Understand how and why to determine best practices.
  • Effectively communicate as well as manage team and stakeholder expectations.

Learn more about bringing this course in-house.

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"This course provided a great overview and the right level of detail on all areas of vendor management.”

Megan Cisneros, Clinical Project Manager
AMAG Pharmaceuticals
on Managing Outsourced Clinical Trials