About the Course
Good project management is key to completing a trial on time and cost effectively. Yet most project managers receive little or no formal training when they move from their operations role (such as CRA). More experienced project managers have little opportunity to learn how clinical trial project management is accomplished in other companies; so that they can extend their range of skills.
This course will demonstrate how a project manager from a single background (e.g. a CRA) can manage a breadth of operational challenges from technical data management issues to strategic interactions with regulatory authorities.
This course spread over four half-days will teach you the difference between doing the work to implement a clinical trial, and project managing the clinical trials team. Giving you tools and techniques, the course will teach how to project manage all of the different components of a clinical trial, from site selection to study closure. From there, you will learn how to detect drift in the timelines or budget, and decide what corrective actions are available to you.
Covid-19 has placed severe travel restrictions across our industry. Whilst visits to sites may be regarded as essential, non-essential travel by a project manager is likely to be curtailed for some time. This course will examine the importance of structured reports and good communications which enable to project manager to remain in control and exercise influence and authority remotely.
A key component of the course is the working exercises and group participation, which translates the theory into practical application.
Key Learning Outcomes
- Overview of the components of clinical research and understanding the project manager’s role
- Identify the key roles and core competencies needed by a project manager
- Learn how to track and interpret project progress
- Assess & manage clinical project/site risks during Covid-19
- Obtain knowledge on various project management techniques
- Understand how the budget and timelines are structured
- Assess the use of various tools in project management
- Introduction to effective vendor management
- Develop clinical study risk management plan & tools
Who Will Benefit
- Project Management
- Clinical Outsourcing
- Clinical Operations
- Contract Management
- Clinical Quality Control
- Finance / Purchasing/ Project Controlling
- Medical Affairs
- Program/Portfolio Management
- CRO Administration and Management
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“A lot of group discussion and communications with different people. The course combined basic definitions and useful practical tools, opening the mind to help attendees see the whole picture of clinical trials”
Secretary of Hospital – GCP Office, The University of Hongkong – Shenzhen Hospital
“It is relevant to the processes we are doing in real world, the trainer is experienced and knows the subject well. Classes are well-organised and engaging with flowcharts, controls, organisational structure”
Associate Director, Tessa Therapeutics
- Definition of project management
- Areas of influence for a project manager
- First steps in forming as project plan
- Project management tools: timelines and flowcharting
WHAT DOES MY PROJECT TRACKING AND REPORTING MEAN?
- Controls and how to control a project
- Choosing which items and processes to control
- Measurement of a project and monitoring performance
- Developing objective criteria for project attributes
- Reporting your project’s progress and status
- Post-covid: keeping on top of your project without an office environment
WHY DO PROJECT AND COMPANY MANAGEMENT STRUCTURES MATTER?
- Organisational structures
- Assigning responsibility for project operations
- Identifying core competencies and developing project team
WORKING EXERCISE: PROJECT MANAGEMENT FOR A CLINICAL TRIAL PROCESS
WHICH PROJECT MANAGEMENT TOOLS AND TECHNIQUES ARE USEFUL?
- Capacity planning and resource allocation
- Conflict resolution
- Risk management plans – what to consider
HOW DO YOU MANAGE COSTS?
- Budgets and timesheets
- Budget planning and tracking
- Budgeting exercise
- Managing scope and budget changes
WHY HAVE ALL THESE PROJECT TEAM MEETINGS?
- Using the time wisely
- Managing stakeholders
- Keeping participants accountable
- Functioning in the “new normal” with increased Covid homeworking
HOW DO YOU APPLY THIS TO CRO OVERSIGHT?
- Types of CRO management
- Maintaining the CRO’s accountability
- Reports and how to know what is happening on your project
WHAT ABOUT DOCUMENTATION?
- Essential documentation required
- Approaches to documenting procedures
CASE STUDIES THROUGHOUT
MULTIPLE GROUP WORK TO PRACTICE AND EXPLORE TOOLS AND TECHNIQUES
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