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