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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 will 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 will learn from top clinical and industry experts, and apply your knowledge in real-world clinical projects. Upon successful completion, you will 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.
The next edition starts in March 2026.
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. 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. The module also covers core statistical concepts relevant to study design, including sample size calculations, confounding, and endpoint selection.
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
- Basic statistical reasoning for clinical research
- Trial initiation, conduct, and closure
- Risk management, audits, and quality assurance
- GCP certification
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. You'll also learn how to manage data in a trial context, from collection and storage to cleaning and analysis.
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
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
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. A new edition starts on March 2, 2026. The project defense date is to be determined at the end of the course.
- 2 March 2026
- 9 March 2026
- 16 March 2026
- 23 March 2026
- 30 March 2026
- 20 April 2026
- 27 April 2026
- 4 May 2026
- 11 May 2026
- 18 May 2026
- 1 June 2026
- 8 June 2026
- 15 June 2026
- 22 June 2026
- 29 June 2026
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): €5,500
- Intermediate rate (academic staff, hospitals, healthcare institutions): €2,500
- Proof of employment in a healthcare/academic institution is required.
- Special rate (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. As this is a postgraduate program, participants are required to register individually. However, invoicing can be arranged via the company or employer if needed.
Completing your registration in the registration tool does not automatically mean that your enrollment is final. You will first receive a confirmation email from us stating that you can participate, together with the invoice. The timing of this communication depends on the total number of confirmed participants. Only after we have received your payment will your enrollment be considered final.
The places are limited. If the maximum number of participants is reached, additional applicants will be placed on a waiting list.
The SME portfolio subsidy (KMO-portefeuille) is requested for this postgraduate.
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 an alumnus/a of UHasselt?
If you completed a UHasselt bachelor’s, master’s, or postgraduate program (in previous years), you can enroll by emailing us at pg.clinicaltrialleader@uhasselt.be with the following information:
- Full name
- Date of birth
- Email address
- Applicable tuition rate and the required proof (as described above)
Questions or need help with your (re-)enrollment?
Contact us at pg.clinicaltrialleader@uhasselt.be
By registering you agree to the specific terms and conditions of UHasselt SEE.
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 must be orally defended before a jury, and the outcome of this defense will determine the final result.
Participants who pass the GCP (Good Clinical Practice) test and attend the required sessions will also receive a GCP certificate.
