Summary
Module 1
Managing a clinical development project is a complex and intricate process. A trial has many factors to rely on to be executed successfully. Clinical Project Management Module 1 will strengthen your understanding of the methods you use when working on clinical development projects and the fundamental tools for planning and follow-up that maximize the efficiency and success of your project as well as your role and responsibilities as project manager.
During the three-day course you will be able to create a project overview, plan and set the objectives. You will work with analysing and managing risks and understand their value to making informed decisions. You will become able to evaluate the collaboration in the project team and know how to deal with stakeholders.
As course participants come from a wide variety of academia, CROs, Medical Device, and pharma companies, network and exchange of experiences will be a big part of this module. We will do our best to take advantage of this by incorporating different experiences and viewpoints to the training sessions. The many practical exercises and discussions are great opportunities for you to strengthen your network.
Since this course is an interactive course with many cases and workshops that put the theoretical concepts into practice we expect you to participate actively.
This course is conducted in English, and is developed in collaboration with IMPLEMENT Learning Institute.
To obtain a Diploma in Clinical Project Management you must complete both Module 1 and Module 2.
Please note that the course fee includes
- Course materials
This is what course participants say
“It was really good and active with workshops etc. which makes me remember and learn more.”
Stine Lauridsen, Global Trial Manager, Novo Nordisk A/S
Keywords
- Clinical Project Management
- Oversight
- Generic Project Management toolbox (tools and techniques)
- Project Management Methodologies
- Clinical Research Methodologies
- Clinical Trial life cycle
- Managing projects with timelines and directions
- Project Risk Management
- Putting the theoretical concepts into practice
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Course leader & lecturers
- Nanna HenriksenCourse leaderManagement Consultant
IMPLEMENT Consulting Group - Kathleen StolpeCourse leaderProject Director
Novo Nordisk A/S
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Is this course for you?
This course is for you who work with clinical project management and want to strengthen your understanding of beneficial methods for planning, optimising, and following up on clinical development projects.
This is the first of the two modules of the Diploma in Clinical Project Management.
What you will learn
- The fundamentals of clinical research project managements
- How to navigate the project environment (governance, regulations, guidelines, SOPs)
- Be able to create an overview, plan, organize and draw up a budget for your project
- How to identify and manage the project stakeholders, CRO, site management and sponsor
- How to plan the clinical trial (milestones, phases and activities)
- How to manage ‘the dynamic cycle of Project Risk Management’ (planning, identification, analyzing, planning risk response, monitoring and controlling)
- How to analyze and manage risks by identifying project critical paths and their value to making informed decisions (‘The Risk’ mindset)
- How to estimate resource requirements (time and costs)
What your company will get
- A professional who understands the fundamentals of clinical research project managements
- A professional who understands the project environment (regulations, guidelines, standard operation procedures (SOPs))
- A professional who is able to create overview, plan, organize and draw up a budget for your project in a clinical setting
- A professional who can identify and manage the stakeholders of a project - CRO, Site Management and Sponsor
- A professional who can plan a clinical trial (milestones, phases and activities)
- A professional who can provide valuable input to all other team members in Clinical Project Management
- A professional who can operate in a highly dynamic and changing environment
Course calendar
Day 1
- Welcome & Introduction
- What is a Project?
- Objective settings
- Stakeholder management
- Project evaluation
Day 2
- Recap Day 1
- Milestone planning
- Sprint planning
- Estimation
- Risk management
- Project LIVE!
Day 3
- Communication
- Project organisation
- Project dilemma
- The role of Project Manager
- Personal Action & Training Plan
- Exam: multiple choice
- Wrap up
- Goodbye and see you at module 2
Registration
Registration deadline22 Jan 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
Module 1: To enrol in this course you must have a relevant educational background at bachelor level and, as a minimum, 6-12 months of experience in project management or other equivalent qualifications. We assess all applications at registration.
If you do not fulfil the requirements, you can still apply for the course if you have experience in the project management area that qualifies you to benefit from the training and enables you to participate actively. We accept that up to 10 % of the seats are taken by applicants who have no or very limited experience in clinical project management. We consider applicants on a case-by-case basis.
Examination
The exam will be a home assignment, which must be handed in approximately one month after Module 2. You will receive individual feedback to help you continue your further development as a Clinical Project Manager.
This course is a part of a diploma
A thorough training for professionals involved in clinical trials giving you proven methodologies and tools you can apply directly. Developed in cooperation with IMPLEMENT and international experts in clinical development.
Read moreCourse leaders
IMPLEMENT Consulting Group
Novo Nordisk A/S
Lecturers
IMPLEMENT Consulting Group
Novo Nordisk A/S
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2 Apr 2025
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Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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