Setting up and running clinical trials is a complex, timely and costly process. It is essential to manage your clinical projects with streamline efficiency to ensure they are completed within set timeframes and to budget. With this in mind, clinical professionals are increasingly looking for ways to improve the results of their clinical projects by implementing project management techniques.
Over 8 modules, this course will examine key management techniques such as analysing stakeholders, assessing risk/benefits and management style.
What Will You Learn
- Identify and communicate the key roles and responsibilities needed through the clinical research project life-cycle
- Examine the core competencies needed to successfully select your clinical research project team
- Bring your projects in on time, within budget and to specification using a Work Breakdown Structure
- Identify the project critical path and use it to make informed decisions
- Remedy key patient recruitment challenges
- Work more effectively both individually and as part of a team
Who Should Attend
All clinical research professionals with limited time for personal development will benefit from the flexible learning approach, including:
- Clinical Research Associates
- Clinical Project Managers
- Assistant Project Managers
- Clinical Trial Manager
- Clinical Affairs Manager
- Study Coordinator
- Clinical Trial Officer
- Clinical Study Coordinator
- Clinical Operations Manager
- Clinical trials monitor
What is an Online Academy course
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
Over 4 Weeks Students Will Learn Through
- 8 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- Revisit the content with unlimited access to all the materials for 2 months
- Access the discussion forum to interact with other students
- Direct contact with the trainer through the forum during the 4 weeks the course is running
- Additional content such as materials and white papers available to download
60 second interview with Ian Stokes on exploring the challenging aspects of managing clinical trials
- What are some of the current trends in the clinical research industry and how the industry changing in the future?
- Why is it important to effectively manage clinical research?
- What are the most challenging aspects of managing a clinical trial?
- What are the top three tips to effectively manage clinical research?
About PTI - Pharmaceutical Training International
PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We have a network of expert trainers who have a minimum of 10 years’ industry experience to meet your training requirements and all our courses are CPD certified.
Our vision is to enhance key skills and competencies to drive continuous innovation and accelerate drug development. When you invest in a PTI course we want you to feel secure, inspired and ready to take on new challenges.
After completing a PTI course, you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.
The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.
“The course structure and format were amazing! Fantastic work Ian!”
Senior Regulatory Affairs Specialist
Benefits of an Online Academy Course
- Learn and apply – implement what you learn during the course
- Become part of a professional learning community – discuss any problems with students and/or the trainer
- Time effective – bitesize chunks so it does not impact on your normal working day
- Cost effective – no travel expenses
- Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
Online Academy Video
Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.
Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at firstname.lastname@example.org to enquire about joining a course after the start date.
Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.
How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.
Who do I contact if I have any problems while the course is running?
You should contact PTI.MDTI.ATIemail@example.com
When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.
How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.
What if I need extra time on the course?
Please contact us at firstname.lastname@example.org if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.
Each module contains approximately 1 hour of content
Review the Nature of a Project and Project Management in Clinical Research
- Project management principles
- Clinical project management challenges
- Portfolio and programme management,
- Drug development timeline
- Project life cycle
- Clinical project management roles and responsibilities
Defining a Mission for the Project and Performing an Analysis of Stakeholders, Risks and Benefits
- Clinical project management documentation:
- Project charter
- Project plan
- Trial master plan
- Clinical protocol
- Standard operating procedures
- Stakeholder engagement
- Project outcomes
- Benefits and risks
- Business cases
Structure and Organise a Clinical Research Project and/or a Clinical Study
- Project needs
- Objectives and requirements
- Work breakdown structure
- Responsibility matrix
Planning an Estimation of Time and Cost (Schedule and Budget)
- Art (participative method) and science (techniques) of estimating effort and durations
- Planning work packages and activities from the Work Breakdown Structure
- Defining dependencies, milestones and deadlines
- Calculating the critical path
- Probabilistic analysis and critical chain
Setting Up a Project Baseline
- Risk management
- Decision making
- Setting up the project baseline (scope, time, cost)
- Managing the project baseline
Managing Suppliers (Contract Resource and Site Management Organisations)
- Appropriate contracting arrangements between clients and suppliers
- Trust-based approaches for setting up a good working relationship
- Patient recruitments challenges, remedies and good practices
Skills and Methods to Improve and Speed Up Your Projects
- Project communication
- Conflict management
- Time management
Closing Out the Project, Learning from Failures and Building from Successes
- Project progress
- Project results management
- Project close-Out
- Learning and improvement processes
when & where
05 - 26 Aug 2019
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.