MODM Clinical Database Management
THE PROGRAM PROVIDES DUAL EXPERTISE IN THE FIELDS OF CLINICAL RESEARCH AND PROJECT MANAGEMENT. IT TRAINS EXECUTIVES SPECIALIZING IN CLINICAL RESEARCH: CLINICAL DATA MANAGERS
OBJECTIVES
The goal is to train professionals specializing in clinical data management and to promote their rapid employability through academic and work-study programs using active learning methods. Master’s 2 specialization.
SPECIFIC KNOWLEDGE GAINED THROUGH THE PROGRAM
- Clinical Trial Monitoring and Logistics
- Essential ICH documents for conducting clinical trials (before, during, and after the trial). GDPR in Clinical Research
- SAS, SQL, and R Programming
- Designing the database based on the CRF
- Quality control, data validation, coding and dictionaries, laboratory data, master file
- CDISC and SDTM Standards, Risk-Based Monitoring
- Outsourcing Management in Data Management
- Using Professional Software
SPECIFIC SKILLS GAINED THROUGH THIS PROGRAM
- ARC Competency in M1
- Set up a clinical database in accordance with CDISC recommendations and in compliance with regulations
- Ability to define the necessary consistency checks to ensure that the database is reliable and complies with the trial protocol
- Program these consistency checks using professional software and SAS.
- Identify and Manage Risks
- Plan and carry out all the necessary quality control steps to ensure a clean database
TEACHING SKILLS AND PROFESSIONAL EXPERIENCE
- Practical training sessions, as well as the APP, have been conducted on the Viedoc eCRF since the start of the 2021 school year, thanks to close collaboration between the training department and the Viedoc team.
- 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
DATA MANAGER IN: CRO – Pharmaceutical Companies – Academic Institutions
IN THE FOLLOWING SECTORS: Pharmaceuticals, Veterinary Medicine, Nutrition, or Medical Devices
Students in the Master 2 program (MODM track: Clinical Database Management) explain why they chose this program and share their vision for the future.
Video: Interview with a graduate who has worked in the professional world and is now employed at EXCELYA for SANOFI, as part of INSIDE IS ISMA
ACADEMIC CALENDAR: 2026/2027/2028
1-Year Apprenticeship (M2), 2026–2027
2-year program: (M1 + M2), 2026–2028