Efficient and well-structured project management is the basis for a successful clinical trial.
The first two days of this seminar provide a thorough and comprehensive insight into the tasks and responsibilities of a Project Manager in clinical research. In addition to learning what a Project Manager does during the various stages of a trial, participants will gain practical tips they can apply in the workplace and useful information about organization, time management and communication strategies, essential for a successful career in project management.
The third day consists of an optional practical workshop. This may be booked additionally. It provides participants with the opportunity to gain first-hand experience in applying project management tools to practical examples and case studies, deepening participants’ understanding, and ensuring lasting results.
This seminar is aimed at professionals and managers working in clinical research and medical affairs departments in CROs or the pharmaceutical industry.
It is particularly suitable for:
- Project Managers / Project Leaders
- Clinical Monitors / CRA
- Study Coordinators
- Medical Managers
On completion of this very practical course you will appreciate the pivotal role of a Project Manager in clinical trials. You will recognize the importance of being able to lead and motivate a team, and of possessing excellent time management, communication and negotiation skills.
You will understand the project life-cycle and the need for contingency planning. You will obtain insight into how study costs are calculated, and learn about capacity planning, budgeting and the monitoring of large international projects.
You will learn how to how to set milestones, analyze risk, and practice these skills using realistic scenarios and standard project planning and decision making tools.
The Project Manager
Roles and responsibilities in clinical trials
The ‘ideal’ Project Manager
Factors for success
Knowledge, skills and competence
The Project Team
Organizing a team
Decision making levels and powers of authority
Delegation and distribution of tasks
Responsibilities and levels of decision making
‘Good communication practice’
Channels of communication and information flow in teams
The goal: a successful and effective project team
The magic triangle: variables under control
Defining the scope and limits of a project
Clinical Trial Operations Plan
Project Management Plan
Establishing a timeline, setting milestones
Efficient project management tools
Planning with MS Project and Excel
Recruitment planning and strategies
Site and investigator selection
Risk management: The contingency plan
Potentials risk areas/ risk categories
Preparation and Conduct of a Clinical Trial
Developing the protocol
Contact with Ethics Committees and Responsible Authorities
Metrics and analyses as aids for project assessment
Allocation and sources of metrics
Validating measuring instruments
Analyzing problems and assessing their severity
Decision making tools
Risk assessment and quality management
Static, analytical or interactive reporting?
Software models and their practicability
Documentation and archiving
Capacity and Budget Planning and Control
Optimum planning of resources
Utilization and experience of CRA
Levels of budget planning
Calculating the budget
Capacity and budget planning in international projects
Budget and manpower planning
Calculating study costs
Acceptable tolerance limits in the event of deviation
By means of practical examples and case studies, participants will be able to practice using various project management tools under the guidance of experienced professionals.
Case Study: From the Planning to the Monitoring of a Clinical Trial
- Brainstorming at the start of a project
- Using mind-mapping to collect and structure ideas
- Drawing up the budget
- What costs need to be included?
- How much of a buffer is necessary?
- Where is there scope for meaningful cost savings?
- Creating the clinical trial operation plan
- What needs to be considered and what has priority?
- What are the timelines?
- What are the strategies for recruitment and what is the time plan for the trial?
- Who is responsible for what and when?
- Communication flow
- Capacity planning
- How much manpower is required for individual parts of the trial and work processes?
- At what point must workforce capacity be ready?
- What can be done to compensate for outage?
- Quantitative decision making models and project control
- Monitoring recruitment – planned vs. actual numbers
- Can timelines be maintained or is there a danger of delay?
- What needs to be done in the event of deviation from plan?
- What are the consequences?
- What measures need to be taken?