Clinical Research Project Management Training Course

What is a Project / Project Management in Clinical research?

• Defining the key characteristics of project management and their importance to Clinical research projects
• Current and emerging ways to manage projects in clinical research including agile project management
• Using a project management process for improving the success of your own clinical research projects
• Sharing experiences and lessons learned from previous clinical research projects

Setting clear project objectives and defining the scope of clinical research projects

• Aligning the project objectives with the strategic and financial business objectives
• Defining the result, the cost and the time
• The project brief or charter or business case

Creating the strategy for your clinical research projects

• Understanding the importance of having an overall strategy for your projects
• Develop and explore options
• Strategic options for clinical trial projects

Detailed project planning of clinical research projects

• Identifying the key project activities using a Work Breakdown Structure (WBS) and defining the work packages
• Allocate responsibilities using the responsibility matrix
• Planning a realistic schedule using Gantt analysis and setting clear milestones
• Clinical trial regulatory and GCP activities – meeting quality expectations
• Resource planning
• Budget planning
• Communication plan, Quality plan and the TMF plan
• Contracts
• Implementing risk management and contingency planning for your clinical research project
• Project management software and tracking systems

Clinical Trial CRO and Service Provider Oversight and Management

• CRO Oversight
• Management of CROs/service providers on clinical research projects
• How milestones measures and reviews are used to enhance visibility and deliver results
• Good practices for managing outsourced clinical trial activities and projects

Patient/subject recruitment and retention

• Improving patient recruitment and retention
• Clinical trial diversity

Project implementation and control for your clinical research projects

• Identifying the possible causes of problems in clinical research projects
• Effective communication and how to manage stakeholders
• Overcoming enablers and constraints of your projects
• Implementing project control and reporting systems
• Metrics and KPIs
• Change requests 
• Monitoring project activities, progress and performance

Project review and closure of clinical research projects

• Close the project
• Identifying the critical success factors and learning from mistakes for continuous improvement

Clinical research Pharma/bio leadership skills

• Defining the role and skills of effective pharma project leaders
• Leadership style
• Improving your interpersonal skills as a leader

Motivate to achieve project milestones

• Understand the principles and practices of motivation
• Understand how to motivate different people and what motivates your project team
• Completion of a self-evaluation questionnaire

Building pharma/bio clinical project teams

• How to modify your leadership style to get the best results in a project team environment
• Understand team management throughout the project life cycle
• Building a high-performance team

Optimising project communication and cross-cultural communication

• Effective communication and how to gain project buy-in
• Preventing and overcoming misunderstandings and dealing with conflict
• Communicating effectively with the project stakeholders including cross-culturally

Technology approaches to improve and speed up your clinical projects

• Emerging industry initiatives for improving, accelerating, and managing clinical trial projects, AI applications.
• Decentralized and hybrid trials

Clinical Trial Project time management

• Identifying and managing common time-wasting activities in your projects
• Maximising your prime time to improve your personal performance
• Develop approaches to optimise time management