MODM Clinical Trials Coordination
THE PROGRAM PROVIDES DUAL EXPERTISE IN THE FIELDS OF CLINICAL RESEARCH AND PROJECT MANAGEMENT. IT TRAINS EXECUTIVES SPECIALIZING IN CLINICAL RESEARCH: CLINICAL RESEARCH ASSOCIATE, INTERNATIONAL CLINICAL TRIAL COORDINATOR
OBJECTIVES
The goal is to train professionals specializing in the role of Clinical Research Associate (CRA) during the first year of the Master’s program. The program is supplemented in the second year of the Master’s program with coursework in project management to prepare students for the role of International Clinical Trials Coordinator. The program is conducted on a work-study basis at major pharmaceutical companies.
Highlights of the Clinical Trials Coordination Track
– Project-based learning
– Career Placement
– Work-Study Program
– In-person guest lecturers (40% in the first year of the master’s program, 70% in the second year)
– Student Monitoring
SPECIFIC KNOWLEDGE GAINED THROUGH THE PROGRAM
Master's Year 1
- Therapeutic Approaches
- Clinical Trial Monitoring and Logistics:
- Regulatory Environment, Preclinical Dossier, Clinical Dossier - Essential ICH documents for conducting clinical trials (before, during, and after the trial).
- Introduction to Clinical Database Management and CDISC Standards.
- Medical Writing in Accordance with ICH Guidelines
Master's Degree (Year 2)
- Project management, planning, and coordination in the conduct of international clinical trials
- Feasibility study, human and financial resource requirements
- Clinical Data Management, Data Management, Risk-Based Monitoring, and GDPR
- Statistical Methods Applied to Clinical Trials
- Pharmacovigilance, Management of Adverse Events
- Subcontracting Management
SPECIFIC SKILLS GAINED THROUGH THIS PROGRAM
- Mastering Project Management: Planning, Cost Management, Schedule Management, and Risk Management
- Develop, coordinate, monitor, and conduct clinical trials
- How to Conduct a Feasibility Study
- Understand international regulations (ICH, FDA, CTD, etc.).
- Understand standard procedures
- Ensure compliance, quality, and data management
- Understanding the Statistical Methodology of Clinical Trials
- Managing Adverse Events, Pharmacovigilance
- How to Write a Clinical Study Report in Accordance with ICH Guidelines
- Managing Outsourcing in the Developer-CRO Relationship
- Adhering to Ethical Standards in Clinical Trials
TEACHING SKILLS AND PROFESSIONAL EXPERIENCE
- Educational Center for 3D Printing in Healthcare. Learning Lab, flipped classroom, interactive seminars, company visits, project-based learning…
- Numerous external professionals
- M1 and M2 programs are open to apprentices; schedules are tailored to optimize hands-on training
CAREER OPPORTUNITIES
ARC, ARC Manager | Clinical Trials Coordinator | Clinical Trials Manager | Clinical Projects Manager
Download the fact sheet for the route
Video: Interview with a student who is both in a sixth-year pharmacy student and an M2 student in Clinical Operations Management as part of INSIDE IS ISMA
ACADEMIC CALENDAR: 2026/2027/2028
1-Year Apprenticeship (M2), 2026–2027
2-year program: (M1 + M2), 2026–2028