DUBLIN–(BUSINESS WIRE)–The “Clinical Research Project Management Training Course (Oct 22nd – Oct 24th, 2025)” training has been added to ResearchAndMarkets.com’s offering.
Setting up and running clinical research projects is a complex process that needs effective project management. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. It is essential to manage clinical research projects within the set time frame, to budget and the right quality standard.
With ever-increasing pressures on clinical research professionals, the use of project management can provide essential tools and techniques and be a key factor in the successful completion of such projects including bringing a drug or medical device to market.
This interactive three-day course has been designed to provide participants with a thorough understanding of both technical and interpersonal project management skills in clinical research projects. Interactive exercises are used to aid the learner in the application of clinical project management concepts and principles so they can easily use the tools to improve the success of existing or future clinical research projects.
Who Should Attend:
This course has been specifically designed to address the needs of clinical research professionals as well as those in the medical device and animal health industries.
The programme will benefit both newly appointed and established project team leaders/managers in clinical research wishing to refresh or update their skills.
Benefits of Attending
- Acquire an in-depth understanding of technical project management methodologies and techniques to apply to clinical projects, including agile project management
- Learn how to incorporate these project management processes into everyday working practices and your current projects
- Understand how to blend together both the technical aspects of project management and the essential interpersonal skills
- Discover how to build core competencies to become an even more effective project manager
- Discuss how to get the best results in a project team environment
The course will be of benefit to:
- Project managers looking to gain experience in clinical research project management
- Project leaders that are unfamiliar with project management tools and principles
- Clinical research professionals transitioning to project management roles/functions
- Clinical trial administrators
- Medical advisers
- Data managers
- Clinical scientists
- Academic and non-commercial clinical researchers
- Regulatory authority professionals
- Service providers including CROs and contractors
Key Topics Covered:
Day 1
What is project management in clinical research?
- 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
Day 2
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
Day 3
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
Certification
- CPD: 18 hours for your records
- Certificate of completion
Speakers:
Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff
Dr Laura Brown MBA, BSc, PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
For more information about this training visit https://www.researchandmarkets.com/r/v4tzm2
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