Advanced Clinical Project Management Training Course

Advanced Clinical Project Management Training Course

Introduction

The field of clinical research is undergoing a rapid, technology-driven transformation, necessitating a shift from traditional task management to strategic project leadership. The modern Advanced Clinical Project Manager (CPM) must expertly navigate the convergence of digital health technologies, complex global trials, and increasingly stringent ICH GCP guidelines. Advanced Clinical Project Management Training Course is designed to equip experienced professionals with the Agile and Hybrid project management methodologies essential for leading high-stakes, multi-site studies. By focusing on cutting-edge topics like Decentralized Clinical Trials (DCTs), AI automation, and Real-Time Data Analytics, this course ensures participants can effectively manage project uncertainty, optimize resource allocation, and drive time-to-market efficiency in a competitive biopharma landscape.

Success in advanced CPM hinges on a foundational understanding of Quality by Design (QbD) and implementing robust Risk-Based Quality Management (RBQM) systems. This program emphasizes moving beyond simple monitoring to establishing a Proactive Risk Mitigation framework across the entire clinical development lifecycle. Participants will master Advanced Vendor Oversight and Stakeholder Engagement strategies, learning to influence C-suite decisions and foster seamless cross-functional collaboration between clinical operations, data management, and regulatory affairs. Graduates will be prepared to lead with emotional intelligence, ensure absolute regulatory compliance, and deliver clinical trials that not only meet scientific endpoints but also achieve superior Organizational ROI.

Course Duration 

10 days

Course Objectives

1. Strategically Integrate Agile and Hybrid project methodologies into complex, adaptive clinical trial designs.
2. Master the principles and implementation of Risk-Based Quality Management (RBQM) aligned with ICH GCP E6(R3).
3. Design and lead effective Decentralized Clinical Trials (DCTs), leveraging eCOA and Telemedicine technologies.
4. Apply advanced Data Analytics and Key Performance Indicators (KPIs) for real-time trial oversight and predictive modeling.
5. Develop robust Regulatory Strategy and ensure seamless global compliance with new guidelines, including CTIS migration.
6. Execute advanced Budgeting and Earned Value Management (EVM) to control costs and forecast financial performance under uncertainty.
7. Implement a comprehensive Vendor Oversight and CRO Management strategy, focusing on performance metrics and relationship governance.
8. Lead Cross-Functional Teams with high Emotional Intelligence and proven Transformational Leadership techniques.
9. Conduct Advanced Risk Assessment using techniques like FMEA and develop robust Contingency Planning.
10. Drive Change Management initiatives related to the adoption of AI and Machine Learning tools in clinical operations.
11. Design and implement a protocol using Quality by Design (QbD) principles to embed quality from the outset.
12. Formulate advanced Patient Recruitment and Retention strategies utilizing Big Data and patient-centric engagement models.
13. Prepare for and successfully navigate regulatory Audits and Inspections across global jurisdictions.

Target Audience

1. Clinical Project Managers.
2. Clinical Trial Managers (CTMs) or Associate Directors.
3. Clinical Research Organization (CRO) Project/Program Leaders.
4. Clinical Operations Directors.
5. Regulatory Affairs Professionals.
6. Data Management Leads.
7. Sponsor/Pharma personnel.
8. Experienced CRAs/CRCs.

Course Modules

Module 1: The Evolving CPM Leadership Role

• Defining the shift from task manager to Strategic Program Leader.
• Developing Executive Communication and influencing C-suite decision-making.
• Mastering Team Dynamics and Transformational Leadership for global, virtual teams.
• Integrating Emotional Intelligence and Conflict Resolution for high-pressure environments.
• Case Study: Leading a high-profile Rescue Trial by re-establishing a clear vision and resolving internal stakeholder conflict.

Module 2: Agile and Hybrid Methodologies in Clinical Trials

• Introduction to Agile frameworks and their applicability in clinical research.
• Designing a Hybrid Model to manage adaptive trial elements alongside fixed regulatory milestones.
• Techniques for rapid Prioritization and continuous integration of Stakeholder Feedback.
• Implementing Rolling Wave Planning and iterative development in study start-up.
• Case Study: Transitioning an existing Phase II protocol to an Agile approach to expedite a critical design amendment.

Module 3: Quality by Design (QbD) and ICH GCP E6(R3)

• Foundational principles of QbD and critical quality factors (CQFs) in protocol development.
• The essential shift to modern ICH GCP E6(R3) principles: quality culture and technological integration.
• Developing the Quality Management System (QMS) for a complex, global program.
• Mapping Process Flow and identifying Critical Data and Processes for quality focus.
• Case Study: Designing a new oncology trial protocol using a QbD workshop to define CQFs and acceptance limits upfront.

Module 4: Risk-Based Quality Management (RBQM) & FMEA

• Establishing the Risk Management Plan (RMP) and using a Risk Assessment Categorization Tool (RACT).
• Advanced Risk Identification using techniques like FMEA
• Developing a Risk Mitigation and Contingency Planning strategy.
• Implementing Centralized Monitoring and Key Risk Indicators (KRIs) for proactive oversight.
• Case Study: Applying FMEA to a complex gene therapy trial supply chain to mitigate temperature excursion risks.

Module 5: Strategic Clinical Data Analytics & KPIs

• Defining and utilizing Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
• Leveraging Advanced Analytics for Predictive Modeling of patient enrollment and site performance.
• Understanding and reporting Real-Time Data for faster decision-making and site interventions.
• Data visualization tools and techniques for Executive Reporting and project transparency.
• Case Study: Using Predictive Analytics to identify and intervene with underperforming sites before critical enrollment deadlines are missed.

Module 6: Decentralized Clinical Trials (DCT) & Digital Health

• Strategic decision-making for implementing DCT components
• Managing the complexities of Digital Biomarkers and patient-generated health data
• Oversight of eCOA/ePRO platforms and ensuring data integrity from remote sources.
• Regulatory and ethical considerations for Telemedicine and remote patient visits.
• Case Study: Managing the operational and technological integration of a fully Decentralized Phase IV study in a geriatric population.

Module 7: Advanced Clinical Trial Budgeting and Finance

• Developing the comprehensive Master Budget and managing Portfolio-level Financials.
• Implementing Earned Value Management (EVM) for tracking financial progress and forecasting completion.
• Techniques for Scenario Planning and managing budget changes due to scope creep or regulatory shifts.
• Optimizing cash flow management and negotiating favorable payment milestones with vendors.
• Case Study: Analyzing a Phase III Budget Overrun using EVM variance reports and developing a recovery plan.

Module 8: Global Regulatory Strategy and Compliance

• Navigating the regulatory landscape: FDA, EMA, NMPA, and other key jurisdictions.
• Understanding and complying with the Clinical Trials Information System (CTIS) for EU trials.
• Managing Global Submissions and country-specific regulatory challenges.
• Preparing the organization for and successfully managing an FDA/EMA Inspection.
• Case Study: Planning the simultaneous regulatory submission and launch of a novel medical device trial across the US, EU, and Asia.

Module 9: Vendor and CRO Management & Oversight

• Developing a strategic approach to Vendor Selection and qualification.
• Negotiating Service Level Agreements (SLAs) and defining clear Contractual Obligations.
• Implementing robust Vendor Performance Metrics and governance frameworks for CRO Oversight.
• Managing complex Multi-Vendor Environments and integration challenges.
• Case Study: Resolving a critical data quality issue by implementing a new CRO Performance Scorecard and corrective action plan.

Module 10: Stakeholder and Communication Management

• Advanced Stakeholder Mapping and power/interest analysis for complex projects.
• Tailoring Communication Strategies for C-suite, investigators, site staff, and patients.
• Techniques for Influencing Without Authority in a matrix organization structure.
• Managing external perceptions and Public Relations during high-visibility trials.
• Case Study: Developing a crisis communication plan for a trial facing unexpected media scrutiny due to a patient safety event.

Module 11: Leading Patient Recruitment and Retention

• Developing a Data-Driven Recruitment Strategy using EMR data and patient population analytics.
• Designing Patient-Centric Protocols to improve retention and compliance.
• Leveraging Social Media and Digital Marketing for targeted patient outreach.
• Strategies for addressing Diversity Action Plans (DAPs) and enrolling underrepresented groups.
• Case Study: Reversing critically low enrollment rates in a pivotal Alzheimer's trial using a patient-centric technology and community outreach program.

Module 12: Project Closeout and Knowledge Transfer

• Mastering the formal Closeout Process for sites, vendors, and the trial master file
• Managing the process of final Clinical Study Report (CSR) writing and regulatory archiving.
• Conducting effective Lessons Learned sessions and final program evaluation.
• Implementing a Knowledge Transfer process to capture key project insights for future trials.
• Case Study: Successfully archiving a 10-year oncology program, ensuring all regulatory and data integrity requirements are met for long-term retention.

Module 13: Artificial Intelligence (AI) and Automation in CPM

• Understanding the application of AI/ML in protocol design, site selection, and document processing.
• Leveraging Robotic Process Automation to streamline clinical operations workflows.
• Ethical and regulatory considerations for using AI in data management and decision-making.
• Assessing vendor capabilities for AI-powered trial services.
• Case Study: Implementing an AI-driven tool for automated analysis of central monitoring data to flag sites for risk-based auditing.

Module 14: Clinical Supply Chain and Logistics Management

• Managing the Complex Supply Chain for Investigational Medicinal Products, including temperature-sensitive logistics.
• Developing strategies for managing drug accountability and reconciliation across multiple global sites.
• Handling the logistics of Ancillary Supplies and laboratory samples for international shipment.
• Implementing a Just-in-Time (JIT) inventory system to minimize waste and costs.
• Case Study: Troubleshooting and redesigning the distribution network for a cold-chain IMP in a multi-country, limited-resource setting.

Module 15: Soft Skills and Advanced Leadership in Crisis

• Developing Executive Presence and gravitas in high-stakes presentations.
• Techniques for leading teams through organizational Change Management and restructuring.
• Practical skills in Negotiation for vendor contracts and budget approvals.
• Leading a Project Crisis with composure and clarity.
• Case Study: Leading an entire organization's operational pivot in response to a global health crisis, maintaining trial continuity.

Training Methodology

The course employs an intensive Hybrid Learning Model combining synchronous and asynchronous activities.

• Interactive Workshops
• Case Study Analysis.
• Expert-Led Discussions.
• Simulations.
• Peer-to-Peer Learning
• Assessment.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.