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CLINICAL RESEARCH TRAINING

Clinical Project Manager: The Essentials

COURSE DESCRIPTION:

The goal of this 2 day training is to provide the essentials of project management, and to go beyond the basics and explore the importance of good project management practices. The course will provide an overview of the PM role and responsibilities, and introduce concepts and tools to aid in effective project management throughout a clinical study. The theme of the training highlights start-up and close-out, strategies for effective communication, documentation best practices, and general tips and tricks.

LEARNING OBJECTIVES:

  • Explain the important role of the project manager throughout a clinical study and how to secure compliance on behalf of the sponsor

  • Explore concepts and tools to aid in day to day activities of project management

  • Describe best practices for managing documentation throughout a clinical study

  • Utilize effective communication and leadership skills for successful study management

COURSE OUTLINE

DAY ONE 8:30 am - 4:30 pm

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

    • Comparing Drug and Device Development Pathways

    • INDs vs IDEs: Comparing 21 CFR Parts 312 vs. 812

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Project Manager Overview: Key Roles and Responsibilities

  • Clinical Research Project Management: Planning and Start-up

    • Creating the Project Plan and Work Breakdown Structure

    • Assessing Risks and Developing Mitigation Strategies

    • Developing Study Documents and Site Files

    • Study Site Start-up: Assessment, Selection, and Initiation

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

    • Thinking Critically about Requirements, Best Practices, and Pitfalls

  • Ongoing Project Management: Documentation
    • Maintaining the Sponsor TMF
    • Documentation in Clinical Research for Sites: What is REALLY Needed
    • What Does GREAT Monitoring Look Like?: “Take Your Team’s Monitoring from GOOD to GREAT!”
    • Excellent Monitoring Reports: What to Look For?
    • Follow-up and Follow Through: Ensuring Effective Site Management by Vendors

DAY TWO: 8:30 am - 4:30 pm

  • Ongoing Project Management: Tools, Strategies, and Effective Communication

    • Effective Metrics: Benefits for Tracking Clinical Study Details

    • Schedule Management and Time Management

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

    • Leading Teams: Managing Difficult Personalities and Having Challenging Conversations

  • Project Close-Out: Getting to the Finish Line

  • 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


HYBRID AGENDA

 

IMARC University Courses

  • Clinical Research Refresher
  • Comparing 21 CFR Part 312 and 21 CFR Part 812
  • The FAIR ShakeTM Method
  • Project Manager Overview

 

One Day Agenda: 8:00am – 5:00pm

  • Ongoing Project Management: Documentation
    • Maintaining the Sponsor TMF
    • Documentation in Clinical Research for Sites: What is REALLY Needed
    • What Does GREAT Monitoring Look Like?: “Take Your Team’s Monitoring from GOOD to GREAT!”
  • Excellent Monitoring Reports: What to Look For?

  • Follow-up and Follow Through: Ensuring Effective Site Management by Vendors

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

  • Thinking Critically about Requirements, Best Practices, and Pitfalls

  • Ongoing Project Management: Tools, Strategies, and Effective Communication
    • Effective Metrics: Benefits for Tracking Clinical Study Details
    • Schedule Management and Time Management

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

    • Leading Teams: Managing Difficult Personalities and Having Challenging Conversations

  • Project Close-Out: Getting to the Finish Line

  • 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 

Training Solutions For These Roles

  • Project Managers
  • Experienced Project Managers without formal project management training
  • Clinical Research personnel interested in transitioning into a Clinical Manager role

TYPE

In Person Training – At IMARC or Your Location
Hybrid training: web-based courses plus in-person training


CEUs

14.0 hours (1.4 CEUs)


KNOWLEDGE LEVELS:

Intermediate
Experienced


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References (Whitepapers and Infographics)
  • Certificate of Completion
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