Course description
Effectively Applying Project Management to Clinical Studies
Clinical trials are unavoidable in the development of drug products and setting up and running them is a complex, timely, and costly process. It is essential to manage your clinical projects with streamlined 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.
Upon completion of this course, you will have the knowledge and skills to lead agile transformation projects and build patient-focused teams. The course breaks down clinical project management into 8 manageable bitesize modules, examining techniques such as analysing stakeholders, assessing risk/benefits, budget control, and management style.
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Upcoming start dates
Suitability - 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
Outcome / Qualification etc.
- 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 challenge
Training Course Content
Module 1: 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
Module 2: 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
Module 3: Structure and Organise a Clinical Research Project and/or a Clinical Study
- Project needs
- Objectives and requirements
- Work breakdown structure
- Responsibility matrix
Module 4: 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
Module 5: Setting Up a Project Baseline
- Risk management
- Decision making
- Setting up the project baseline (scope, time, cost)
- Managing the project baseline
Module 6: 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
Module 7: Skills and Methods to Improve and Speed Up Your Projects
- Teamwork
- Project communication
- Conflict management
- Motivation
- Time management
Module 8: Closing Out the Project, Learning from Failures and Building from Successes
- Project progress
- Project results management
- Project close-Out
- Learning and improvement processes
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5