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.
Manage projects and quality risks
Formulate project priorities and approach to building quality into project needs
Describe effective leadership skills in leading study teams
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”
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
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
