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CLINICAL RESEARCH TRAINING

CLINICAL PROJECT MANAGER: ADVANCED CONCEPTS

COURSE DESCRIPTION:

This course provides the experienced Clinical Project Manager with the advanced project management and leadership skills to effectively lead project teams to their optimal performance. Advanced concepts will be presented to explore how project managers can effectively prioritize project needs, lead project teams and utilize best practices for decisions. Topics explored include assessment of risk, project quality, effective study management, and corrective and preventive action (CAPA) plans.

LEARNING OBJECTIVES:

  • Manage projects and quality risks

  • Formulate project priorities and approach to building quality into project needs

  • Describe effective leadership skills in leading study teams

COURSE OUTLINE

AGENDA: 8:30 am - 4:30 pm

  • Good Clinical Practice and U.S. FDA Regulations Refresher

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Building Quality into Clinical Research Studies

    • Conducting Risk Assessment: Identifying , Evaluating, and Mitigating Risks

    • Risk Management: Implementing Approaches for Compliance

    • Risk-Based Monitoring Throughout a Study: Best Practices

    • Corrective Actions Plans: Identifying, Documenting, and Implementing to Improve Site Compliance

  • Effective Project Management: Tools and Strategies

    • Effective Metrics: Benefits for Tracking Clinical Study Details

    • Schedule and Time Management

    • How to Run Effective Meetings: 8 Steps to a Successful Meeting

    • Working with Your Monitors to Ensure Timeliness, Quality, and Study/Site Compliance

    • Leading Teams: Managing Difficult Personalities and Having Challenging Conversations

  • Research Off the Rails: Getting Your Clinical Study Back on Track

    • “What do I do when I realize there is a problem?”

  • Project Management in Practice: 5 Things That Aren’t (Normally) Taught in PM Class

  • FDA’s BIMO Program: Inspection of Sponsors, CROs, and Monitors – “Preparing for Inspection Success from Day 1”

 

ADDITIONAL WEB-BASED COURSE ADD-ONS

  • Critical Thinking in Clinical Research

  • Project Manager Overview

  • Maintaining the Sponsor TMF

  • FDA Inspectional Findings

  • Comparing 21 CFR Part 312 and 21 CFR Part 812

 

Training Solutions For These Roles

  • Experienced Project Managers

TYPE

In Person Training – At IMARC or Your Location


CEUs

7.0 hours (0.7 CEUs)


KNOWLEDGE LEVELS:

Intermediate
Experienced


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion
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