Course Description

This introductory project management course covers concepts from the Project Management Institute, PMBOK® 6th and 7th editions, and how they specifically apply to clinical research. The course is designed for newly hired clinical project managers, clinical project managers without formal project management training, or those exploring the clinical project management role. Principles of clinical project management are covered, including project stakeholder and team engagement, project planning, scope and budget management, risk identification, risk management, and schedule management in the lifecycle of a clinical trial. Case studies and learner discussions are utilized throughout the modules to reinforce concepts covered during this two-day interactive, hands-on program.

Learning Objectives

• Describe project management as it applies to clinical research
• Explore stakeholder and team engagement in project lifecycle management 
• Define scope management and tools utilized by project managers, including the work breakdown structure, process mapping, and schedule management
• Identify how project managers work with the clinical operations team and stakeholders in risk identification, risk planning, and risk management  
• Define effective vendor management and sponsor oversight in clinical trial projects 

Who Should Attend

• Clinical Project Managers and Clinical Trial Managers from pharmaceutical, medical device, or CRO industry with less than two years working in their role
• Experienced Clinical Projects Managers without formal clinical project management training
• Newly Hired Clinical or Project Team Leaders who will be managing projects (either at the sponsor, CRO, or investigational site)
• Clinical Research Associates, Data Managers, or other members interested in transitioning into the Clinical Project Management role or Clinical Trial Management 

Instructor

The course will be led by one of the following instructors:

Shelley Marti, M.S.N., P.M.P.

Danny Nasmyth-Miller, B.A. (Hons.) M.B.A.

Nazma M. Rosado, MAOL, P.M.P., CPLP, 6σ, CMQ/OE 

Click here for complete trainer biographies

Course Outline

Day One

• Module 1: Introduction to Clinical Project Management: Overview of project management as defined by PMI®; roles and responsibilities of the clinical project manager; establishment of project teams
• Module 2: Project Planning: Scope identification, planning, and schedule planning
• Module 3: Effective Schedule Management: Defining project scope; creation of a project schedule; identify critical path; effectively project scope changes and impact to project schedule 

Day Two

• Module 4: Budget Planning: Introduction to budget estimates, development of a project budget, and budget tracking 
• Module 5: Project Risk and Quality Management: Introduction to ICH GCP E6 (R3) and ICH E8 (R1) (risk identification, risk planning, risk register, and critical to quality) 
• Module 6: Vendor Management: Vendor selection process, sponsor oversight and success factors 

Interactive Activities

• Case Study: Creation of Work Breakdown Structure (WBS)
• Case Study: Development of a project WBS and project schedule
• Case Study: Investigational Product Risk 
• Case Study: Risk Double Blind Study Design 
• Case Study: Risk Dosing of Investigational Product 
• Case Study: Using a third-party Vendor

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-002-L99-P. Released: 3/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.