Course Description

This two-day advanced course delves into advanced clinical research project management skills, mapped to the Project Management Institute, PMBOK ® 6th and 7th editions.  This course is recommended for the experienced clinical project manager with a minimum of three years of clinical project management experience. Advanced concepts are presented to explore how project managers effectively communicate and lead project teams to overcome complex issues, including prioritizing project needs, influencing and leading project teams and stakeholders.  The course also covers challenges in vendor lifecycle management, project risk assessment (project, quality), and issues management. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.

Learning Objectives

• Explain project management tools and principles used in clinical trials
• Formulate project priorities and approach to effectively manage project needs
• Develop effective communication and leadership skills for the project needs
• Identify critical to quality factors and risks in clinical trial project
• Appraise effective stakeholder and vendor management in clinical trials
• Describe effective leadership skills in leading project teams

Who Should Attend

• Project Managers
• Clinical Research Coordinators, Associates, Monitors, and Managers
• Regulatory, Medical, and Clinical Affairs Professionals

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

• Introduction: Review of clinical project charter, project plan, project risk analysis, and use of various tracking methods in project management
• Importance of the Project Team: Your team is the key to project success
• Prioritization Management: Priority setting to manage project schedule and workload
• Managing Projects: Stakeholder management and effectively leading/directing/influencing project teams

Day Two

• Project Risk and Critical to Quality Factors: ICH GCP E6 (R3) and ICH E8 (R1) in the conduct and management of a clinical trial
• Project Vendor Management and Oversight: Ensuring successful vendor oversight and issue management

Interactive Activities

• Case Study: Prioritization management for the clinical project manager and effective delegation
• Case Study: Stakeholder identification, interests, and considerations for effective management
• Discussion: Effective leadership skills, per the topic or situation encountered
• Case Study: Identify project risks and implement a treatment plan
  
• Case Study: Stakeholder and vendor management

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#: 0778-0000-24-003-L99-P. Released: 3/24.

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