Advanced Clinical Project Management
About this course
Reasons to attend
You want to advance your clinical project management skills to be more effective in your daily work? This course will provide you strategies and tactical information to overcome the most difficult project circumstances encountered and allow you to be more visible within your company.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
- 2-Day face-to-face training: 09:00 - 17:00
- 6 Webinars of 2 hours
Course Description
During this course, you will get the chance to advance essential skills needed in the senior PM position you are in or aiming for. You will get to know the Quality by Design (QbD) principles and how to take a solution-oriented approach to resolving problems. Advanced concepts will be presented, including building team performance, budget and timelines management, ensuring adequate patient enrolment potential before beginning a trial, strategies when enrolment is not progressing as planned, etc. Tips and tricks on how to track delay and prevention, advanced concepts around vendor contract management and reporting techniques are presented to make your project successes more visible within your organisation and beyond.
You will learn the basics for setting a team vision since vision building should not only be as clear as possible to team members, it should also be as meaningful as possible for project success. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.
Programme highlight
- Quality by design concept and implementation
- Estimating global study enrolment and recruitment enhancement activities
- Manage operational challenges in patient recruitment
- Setting Key Performance indicators
- Budget management challenges
- Tips and tricks to keep study oversight
- Reporting techniques
- Reminders on vendors contract principles: Statement of Work (SOW), Task Order Agreements (TOA), letter of Intent etc. and their impact on the study budget management
- Vision building for your organisation, your team and yourself
Learning objectives
- Incorporate Quality by Design (QbD) principles, metrics, and tracking in the clinical operations plan
- Estimate study enrolment, and produce the schedule
- Discuss how to evaluate and improve an ongoing clinical trial or program.
- Know the PM role within the wider organisation
- Be more comfortable in budget management
- Be able to present the study status in a solution focused way.
- Recognise the importance of the team within the successful study execution
- Be able to work with their teams on vision building
- Know which of the 5 building blocks to explore first with your team members
Who should attend
- Senior Project Managers who want to set new goals and objectives in their career and wish to advance and/or refresh their technical and behavioral skills.
- Prior experience in and/or knowledge of Clinical Research management is required
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (8)
- Data Management and Informatics (1)
- Leadership and Professionalism (2)
- Communication (3)
- Teamwork (1)
- Business acumen (3)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
Dr. Paula Hemdal
Trainer
Dr. Marika Leenders
Medtronic
A very good one day course! I learned a lot from the trainer and the other participants. The assessment afterwards also made you revisit the materials received, which was very useful.
Unfortunately the number of participants was limited, this would have triggered discussions even more. But overall a very positive experience!
Karine Barthe
Keyrus
Going into deep on some topics was very useful to understand why we have to do these tasks, what is expected and how to do them in a better way - Based on what was discussed during training I will improve my actual monthly progress report - workshops were very well adapted to our needs.
Charlotte Vandenrijn
Galapagos
Workshops were very useful to share best practices.
Samia Abed Maillard
Lausanne University Hospital
The course was really great and the teachers were excellent allowing a good interexchange between participants with different professional experiences and backgrounds. This interaction was very beneficial. Thank you for this opportunity to learn.
Daniele Oberti
SAKK
I got a systematic overview of topics relevant for a senior CPM position with a special focus on patient’s perspective. The classroom was made in an ideal way to allow us to discuss and exchange ideas.
Anonymous
MABXIENCE Research