Course Description
This two-day intensive program is designed for experienced clinical research professionals seeking to elevate their expertise in project leadership, strategic thinking, and operational excellence. Built around globally recognized project management standards and tailored specifically for the clinical research environment, this course provides advanced, real-world strategies for managing complex trials, optimizing vendor partnerships, mitigating risk, and motivating high-performing teams. Participants will gain knowledge, tools, and leadership confidence to successfully oversee global studies from start-up to close-out while earning PMI-recognized Professional Development Units (PDUs).
Course Summary
Upcoming Courses
Learning Objectives
Upon completion of this course, participants will be able to:
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Apply advanced project management concepts and tools specific to clinical trials.
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Develop strategic study timelines and proactively manage critical path activities.
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Lead effective bid defense meetings and assess vendor capabilities.
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Oversee study initiation, regulatory readiness, and site activation processes.
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Interpret and manage contracts and budgets throughout the project lifecycle.
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Monitor site performance using key study metrics to drive accountability.
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Identify and mitigate quality risks while implementing CAPA and audit strategies.
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Demonstrate effective communication, negotiation, and leadership techniques tailored to clinical research environments.
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Successfully execute close-out processes and prepare for regulatory inspections.
Who Should Attend
This program is ideal for clinical research professionals with at least three years of experience who are ready to advance into strategic leadership roles, including
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Clinical Project Managers and Senior Project Managers
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Clinical Operations Leads and Study Managers
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Clinical Research Associates and Site Management Professionals
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Regulatory Affairs, Medical Affairs, and Clinical Development Leaders
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Professionals responsible for oversight, governance, or decision-making in clinical trials
Course Outline
Module 1
Introduction to Clinical Project Management
Module 2
Bid Defense, Vendor Selection & Management
Module 3
Project Schedule & Resource Forecasting
Module 4
Study Initiation and Activation
Module 5
Project Management Technical Knowledge
Module 6
Study Contracts and Budget Management
Module 7
Site Monitoring, Management & Metrics
Module 8
Quality and Risk Management
Module 9
Communication and Leadership
Module 10
Study Close-Outs and Audits
Total Duration: 16 Hours (2 Days)
Total PDUs: 16 PMI-Approved (Technical: 9 | Leadership: 5 | Strategic: 2)
January 24 - 25, 2026
9:00 am. - 4:00 pm. EST
Take advantage of our $1795.00 price by registering early!
* After December 24, 2025, costs are $1,995.00
Interactive Activities
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Study Lifecycle Mapping: Participants build the full clinical trial lifecycle, identifying PM responsibilities at each phase.
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Bid Defense Simulation: Teams conduct a live vendor selection and bid defense scenario with scoring and negotiation.
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Schedule Strategy Exercise: Participants construct a detailed project timeline and respond to delay scenarios.
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Site Activation Case Study: Learners develop an optimized start-up and activation plan for a multi-country study.
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PM Tools Challenge: Teams use real PM tools (risk log, RACI, dashboard) to resolve simulated study challenges.
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Budget Negotiation Roleplay:Participants negotiate contract terms and handle change orders under pressure.
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Enrollment Rescue Drill: Teams review metrics and develop a corrective action plan to rescue underperforming sites.
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Risk & CAPA Workshop: Participants conduct a root cause analysis and create a CAPA plan using inspection findings.
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Stakeholder Influence Roleplay: Individuals practice influencing without authority in conflicting stakeholder scenarios.
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Audit Simulation: Participants engage in a mock audit, submit responses, and prepare a close-out checklist.
