Project Management in Clinical Research

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.
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

Speaker:

Marina MalikovaExecutive 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.

For Registration -  https://www.complianceonline.com/clinical-research-project-management-seminar-training-80592SEM-prdsm?channel=eventbrite        

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