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.
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
DAY ONE 8:30 am - 4:30 pm
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
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
One Day Agenda: 8:00am – 5:00pm
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
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
In Person Training – At IMARC or Your Location
Hybrid training: web-based courses plus in-person training
14.0 hours (1.4 CEUs)
Intermediate
Experienced
