ECTS
120 credits
Duration
2 years
Training structure
School of Pharmacy
Language(s) of instruction
French
Presentation
The aim is to train executives specializing in clinical data management and promote their rapid employability through academic and work-study training using active teaching methods. Specialization in Master 2.
Objectives
Training engineers in the field of health and clinical research
Know-how and skills
Dual expertise in clinical research and project management.
Mastery of the tools required for clinical trial management, project management tools, and the risks associated with conducting clinical trials.
Mastery of clinical trial methodology: regulations, cost and budget, planning and implementation, risk management, auditing, pharmacovigilance, subcontractor management, etc.
Master all stages of managing a clinical trial database in accordance with regulations and good clinical practices (designing the database based on the protocol and CRF, quality control, programming data consistency checks, validation plan, coding adverse events, importing laboratory data, database freeze, etc.).)
Organization
Open alternately
Type of contract | Apprenticeship contract, Professional training contract |
|---|
According to the provisional schedule provided by the training program.
Program
The M1 trains students for the profession of Clinical Research Associate, then in the M2 students choose one of two sub-specializations: Clinical Database Management or Clinical Study Coordination.
Select a program
Master 1 Clinical Operations Management and Data Management (MODM) - Data Management track
Master 1 Clinical Operations Management and Data Management (MODM) - Data Management track
Databases – Epidemiology and Environmental Health
5 creditsHealthcare Product Development Team – Project Management and Clinical Development
5 creditsElective EU Semester 1
5 creditsRegulatory and financial aspects, Quality and safety TC
5 creditsBiotechnology applied to health
5 creditsModern Languages and Communication
5 creditsEnglish Semester 1
Modern languages
Choose 1 out of 3
Spanish Semester 1
2.5 creditsGerman Semester 1
2.5 creditsOther language Semester 1
2.5 credits
Documentation and communication
Regulatory Affairs, BPC, Pharmacovigilance
5 creditsInternship
10 creditsMonitoring and logistics of clinical studies
5 creditsEnglish and second language
5 creditsEnglish Semester 2
2.5 creditsModern languages Choice 2
2.5 creditsChoose 1 out of 3
Introduction to clinical database management
5 credits
Master's Degree in Clinical Operations Management and Data Management: Data Management Track
Master's Degree in Clinical Operations Management and Data Management: Data Management Track
And after
Gateways and reorientation
other equivalent master's degrees
Professional integration
Jobs related to clinical research (pharmaceutical industry, CRO, clinical investigation center, public health institution, etc.):
Clinical database manager (Data Manager) (http://www.leem.org/gestionnaire-de-donnees-biomedicales)
Clinical Research Associate (http://www.leem.org/attache-de-recherche-clinique)
Clinical trial coordinator or manager (http://www.leem.org/attache-de-recherche-clinique-manager)