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Postgraduate Clinical Trial Leader
Postgraduate - 20 ECTS (studiepunten) - English
Are you a life sciences professional, looking to deepen your understanding of clinical trials and expand your practical skill set, possibly eager to grow into a leadership role within clinical research? Ready to strengthen your practical knowledge with data science and project management skills?
The Postgraduate Program in Clinical Trial Leadership offers a unique opportunity to explore the real-world dynamics of clinical research. You'll gain hands-on experience in Good Clinical Practice (GCP), clinical study design, data science fundamentals, and project management/leadership, all integrated into one applied training track.
Our face-to-face sessions are interactive and intensive, spread over 15 Mondays at UHasselt. You’ll learn from top clinical and industry experts, and complete an individual project rooted in real-life clinical settings. Upon successful completion, you’ll receive both a postgraduate certificate and a GCP certificate.
This program also offers invaluable networking opportunities and personalized leadership development to prepare you for your next career step as a clinical trial leader.
Next Edition
Start of the postgraduate lessons 1/02/2027 - The program will run subject to a minimum number of registrations.
Registration open from 1st Sept 2026 - 15th Dec 2026
You can already pre-register if you want to be informed about this course.
Be aware though that pre-registration does not imply that you are officially registered.
Official registration can be done from September 1st onwards.
For whom?
- You hold a master’s or professional bachelor’s degree in life sciences, medicine, or a related field.
- Applicants with a professional bachelor’s degree may be admitted after evaluation by the academic coordinator. An intake interview may be part of the process.
- You are a student or (early-career) professional in clinical research or healthcare.
- You want to gain practical skills in GCP, data science, and project management.
- You aim to contribute more actively to clinical trials, now or in the future.
- You are motivated to combine academic training with real-world applications.
Program
The postgraduate program Clinical Trial Leader has a modular structure, consisting of three integrated modules. These modules are intertwined and cannot be followed separately at the moment. The program is designed as one coherent whole to support the successful completion of an individual project.
Module 1: Good Clinical Practice (GCP) & Clinical Studies
Module 1: Good Clinical Practice (GCP) & Clinical Studies
This module provides a comprehensive overview of how clinical trials are designed, initiated, and conducted according to Good Clinical Practice (GCP) standards and applicable European and national regulations. It introduces you to key ethical, legal, and methodological principles that govern clinical research today.
You will learn how to critically assess and contribute to clinical protocols, understand trial phases, and navigate key regulatory requirements such as GDPR, insurance policies, ethical approvals, and informed consent. In addition, you will gain practical insights into the real-world conduct of trials: budgeting, stakeholder involvement, site initiation, trial monitoring, deviations, data handling, and safety reporting (pharmacovigilance). The final sessions address the close-out phase, including database locking, final reporting, audits, and inspections.
The module concludes with a preparation session and test for GCP certification.
Key topics include:
- GCP principles and legal/ethical frameworks
- Clinical trial design, study types, and protocol development
- Regulatory aspects: GDPR, insurance, ethical committees
- Trial initiation, conduct, and closure from an operational perspective
- Risk management, audits, and quality assurance
- GCP certification test
Lecturers:
Phara
Nele Claes
Hilde Kelchtermans (LCRC)
Katherine Tartaglia (ZOL)
Katrien Witters, Lieselotte Lemoine, Astrid Devos, Anneleen Van Orshoven (Jessa)
Module 2: Data Science
Module 2: Data Science
This module introduces key data science concepts tailored to clinical research settings. You will gain a foundational understanding of statistical reasoning, study design, and data interpretation, skills essential for critically evaluating and applying data in clinical trials.
Starting from basic terminology such as types of variables and study designs, the module moves on to explore core topics like hypothesis testing, summary statistics, and the distinction between causation and correlation. Advanced sessions dive into modeling approaches relevant for clinical data, including parametric and non-parametric tests, handling missing data, multivariable models, survival analysis, and meta-analysis. Special attention is given to real-world data (RWD), digitalization trends (e.g., wearables), and working with biomarkers and surrogate endpoints.
Key topics include:
- Observational vs. interventional study design
- Types of data, variables, and statistical models
- Hypothesis testing and summary statistics
- Handling missing data and confounding factors
- Regression models, non-linear models, and survival analysis
- Meta-analysis and validation of biomarkers
- Digital health data and wearables in clinical research
Lecturers:
Liesbeth Bruckers DSI
Anna Ivanova DSI
Module 3: Project management & Leadership
Module 3: Project management & Leadership
This module equips you with essential skills to successfully plan, manage, and complete clinical trial projects. You’ll learn key project management concepts, roles, and best practices tailored to the clinical research setting.
Topics include project setup (charter, stakeholder identification and engagement), detailed planning (team building, budgeting, deliverables), and execution (budget monitoring, communication, change management). You will also master project monitoring using KPIs and dashboards, and ensure quality through effective project closure.
Leadership skills are integrated throughout, focusing on personal leadership, team empowerment, coaching, collaboration, negotiation, and conflict resolution.
Key topics:
- Project management principles and approaches
- Role and competencies of the project manager
- Stakeholder management and engagement
- Project planning: teams, budget, deliverables
- Execution: communication, change management, process optimization
- Monitoring: KPIs, reporting, dashboards
- Project closure and quality improvement
- Leadership: personal development, coaching, teamwork
- Collaboration, negotiation, and conflict management
Lecturers:
Leon Vliegen, Founder of FLY, Senior Consultant & Executive Coach, Guest Lecturer at UHasselt
Timing
Contact hours are scheduled on Mondays from 1:00 PM to 8:00 PM. Holiday periods are taken into account. Each class day consists of 6 contact hours, totaling 90 contact hours.
The project defense date is to be determined at the end of the course.
- February: 1, 15, 22 (8 feb krokusvakantie)
- March: 1, 8, 15, 22, (29 mar-11apr paasvakantie)
- April: 12, 19, 26
- May: 3, 10, 24, 31 (17 mei pinkstermaandag)
- June: 7
Oral defense of individual project 21, 28 June
Location
- Campus Diepenbeek, Building D
- Easily accessible by train, bike, bus, and car
- Just a 20-minute bike ride from Hasselt city center
Campus Diepenbeek - gebouw D
Agoralaan - gebouw D, 3590 Diepenbeek
Registration & Tuition Fees
Tuition fees for the full postgraduate program:
- External rate (companies, external partners): €3.750
- Intermediate rate (hospitals, healthcare institutions): €2.500
- Proof of employment in a healthcare/academic institution is required.
- Special rate (academic staff, students, PhD candidates): €1.250
- Proof of student enrollment of academic year 2025-2026 or academic status is required.
Please note: Modular registration for individual course components is not available. You must register for the full program. The tuition fee includes study materials.
The program will only be organized if a sufficient number of participants enroll. To ensure smooth planning, registration closes on 15th December 2026. As this is a postgraduate program, participants are required to register individually. However, invoicing can be arranged via the company or employer if needed. Once your registration is confirmed, you will receive a secure payment link. The timing of this communication depends on the total number of confirmed participants.
Please note that places are limited. If the maximum number of participants is reached, additional applicants will be placed on a waiting list.
You may be eligible to use the SME portfolio subsidy (KMO portefeuille) under the themes of 'Business Strategy' and 'Financial Literacy'. Our recognition number is DV.O101614 .
This course is eligible for Flemish training leave.
How to Register
Are you a new student at UHasselt?
If you have never enrolled in a bachelor’s, master’s, or postgraduate program at UHasselt, or it has been a long time since you last did, you must register as a new student.
Create your UHasselt account and follow the steps in the registration tool
Need help? Follow the step-by-step guide for new registrations.
Are you a PhD candidate?
Please contact doctoralschools@uhasselt.be to submit your application.
Are you an alumnus/a of UHasselt?
If you completed a UHasselt bachelor’s, master’s, or postgraduate program in the previous academic year, you can re-enroll by following the re-enrollment guide.
Questions or need help with your (re-)enrollment?
Contact us at pg.clinicaltrialleader@uhasselt.be
Evaluation & Certification
To obtain the postgraduate certificate, participants must successfully defend their final project and demonstrate sufficient attendance throughout the program. The structure of the program is designed to support the successful execution of this project. Therefore, active participation and consistent presence are essential. The project may be: a real-life case provided by the participant’s organization, or a fictional case study offered by UHasselt. It must be orally defended before a jury, and the outcome of this defense will determine the final result.
Participants who pass the GCP test and attend the required sessions will also receive a Good Clinical Practice (GCP) certificate.
