Course overview
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.
The ICH GCP E6(R3) guideline introduces significant updates that reflect modern clinical trial practices, especially regarding risk-based quality management, digital technology, and participant-centricity. For clinical research project managers, these updates have direct implications for how trials are planned, conducted, monitored, and reported. The course will cover the key implications and changes that project managers must be aware of.
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.
CPD Hours: 18
Course Content
- Day 1
- What is project management in clinical research?
- Setting clear project objectives and defining the scope of clinical research projects
- Creating the strategy for your clinical research projects
- Detailed project planning of clinical research projects
- Day 2
- Clinical trial CRO and service provider oversight and management
- Patient/subject recruitment and retention
- Project implementation and control for your clinical research projects
- Project review and closure of clinical research projects
- Day 3
- Clinical research pharma/bio leadership skills
- Motivate to achieve project milestones
- Building pharma/bio clinical project teams
- Optimising project communication and cross-cultural communication
- Technology approaches to improve and speed up your clinical projects
- Clinical trial project time management
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical project management and training consultant. Laura has more than 25 years’ experience of managing clinical research projects in the pharmaceutical industry and has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has worked as a Life Cycle Project Manager, Clinical Research Project Manager and Head of a Training organisation in the Pharmaceutical industry. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including Project Management for the Pharmaceutical Industry.
