This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process.
This course examines the concepts and applied techniques for cost estimation, risk management and quality assurance for clinical research projects. Project management principles and methodology are provided with special focus on planning, controlling, and coordinating individual and group efforts. Key topics include overview of modern project management in clinical trials, organization strategy and project selection, defining a project and developing a project plan and scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks through lectures, case studies and discussions will provide a significant competitive advantage in the marketplace for clinical research professionals.
Learning Objectives:
- Describe project management as it applies to clinical research and in the management of clinical trials
- Identify how project managers develop high performance project teams
- Develop a project plan and work breakdown structure
- Identify process mapping tools used in clinical research
- Recognize the importance of effective project schedules
- Identify clinical trial project budgetary needs
- Identify performance metrics and utilize effectively to monitor project
- Management of vendors within a clinical trial for optimal oversight and outcomes
- Implement successful project closure and lessons learned
Areas Covered:
- Prioritization and strategies in planning clinical studies
- Recourses allocation
- Outsourcing strategy
- Assigning role and responsibilities of study team members
- Cost estimation and budgets for clinical project
- Establishing schedules, timelines to meet corporate goals
- Risk Management and Quality Assurance strategies
Who will benefit:
- New Project Managers
- Project Managers with little or no drug development or clinical trial experience
- Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New Clinical or other Project Team Leaders who will be managing projects
- Managers unfamiliar with clinical project management
- New Clinical, Regulatory, and Department Staff who will design clinical trial programs
- Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
- Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers
- Grant Administrators
- 8:30-9:00 Registration Meet & Greet
- 9:00 -11:00 AM Introduction to Clinical Project Management: Overview of project management; roles and responsibilities of the clinical project manager; establishment of project teams.
- 11:00- 12:00 AM Strategic Project Planning: Review of the project charter; risk identification to clinical research projects; development of a project plan; creation of the work breakdown structure in a project.
- 12:00-1:00 Lunch
- 1:00-2:30 PM Process Mapping as a Planning and Management Tool.
- 3:00-4:30 PM Effective Schedule Management: Defining project scope; creation of realistic schedules; identification of critical path to a project; effectively managing change orders and out of scope to your project.
- 8:30-9:00 Meet & Greet Questions for the Instructor
- 9:00 -11:00 AM Costs Estimation, Creation and Management of Budgets: Effective project budget planning and tracking.
- 11:00AM-12:00PM Outsourcing Strategies. Vendor Management and Oversight: Qualification, selection, and oversight of vendors in clinical research projects.
- 12:00-1:00 LUNCH
- 1:00- 2:00 PM Tracking Projects: Risk, Cost and Change Management. Development and Implementation of Quality Control and Risk Management Systems and Key Performance Indicators.
- 2:00- 2:30 PM Project Closure: Effectively closing a project and lessons learned.
- 2:30-2:45 PM Refreshments Break
- 2:45 – 3:45 PM Group work on the Case study
- Case Study: Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Techniques Applied to the Planning and Execution of a Clinical Trial.
- 3:45-4:30 PM Discussion of the Case study and Closing remarks
Marina Malikova
Executive Director at Boston University School of Medicine
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
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