This course has been designed to cover the principles and practice of Project Management applied to clinical project management in the pharmaceutical industry.  

Program outline:

  • What Is A Project ?
  • Process & Content
  • 7 Elements Of Project Management
  • Evolution Of Project Management
  • Elements of a Project
  • Phases of a Project
  • Roles and responsibilities of project managers across the project life cycle
  • Foundations of a project plan
  • Project requirements document, work breakdown structure, cost, schedule and other resources
  • Control the project against the baseline
  • Close out of a project
  • Project management knowledge areas
  • Example of a new product launch process (Pharmaceutical) with Gantt chart
  • Project charter mind map
  • Clinical Research: multiple project development and Gantt charts
  • Tasks for preparing a study project
  • Tasks for protocol design and development
  • Tasks for setting a trial management system
  • Tasks for enrolment plan
  • Tasks for ICF development
  • Tasks for drug supplies
  • Tasks for vendor contracting and training
  • Tasks for centralized testing centres and labs
  • Tasks for site selection
  • Tasks for investigators contracting
  • Tasks for related regulatory submissions and approval
  • Tasks for investigator meeting
  • Tasks for monitoring plan
  • Tasks for site initiation
  • Tasks for study conduct
  • Tasks for database management and review
  • Tasks for database finalization
  • Tasks for completing the statistical report
  • Full list of tasks and descriptions for managing a clinical trial  

 








This program covers the following:

1- The Canadian Healthcare System

2- Components of the Canadian health care system

3- Canadian and American Healthcare policies

4- Principles of Healthcare Administration

5- Labor relations and Canadian labor law

6- Information management for the Canadian Federal Government

The Certificate program in Project management includes the following topics:

  • What is a project?
  • Project management
  • Project Lifecycle
  • Project Management Knowledge
  • Project Management Skills
  • Project Management Tools and Methodologies
  • Project Budget
  • Project Governance
  • Project Management Techniques
  • Project Stakeholders
  • Portfolio Design
  • Planning
  • Scheduling
  • Resource Allocation
  • Human Factors
  • Decision Making
  • Process Leadership and Benchmarking
  • Flow Diagram
  • Multiple Project Dashboard
  • Project Status Report