ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Language(s) of instruction
French
Presentation
The aim is to train managers specializing in Clinical Data Management, and to promote their rapid employability through academic and work-study training. Specialization in Master 2.
Objectives
Train engineers in the field of healthcare and clinical research
Know-how and skills
Dual skills in clinical research and project management.
Master the tools needed to manage clinical trials, master project management tools, master the risks associated with clinical trials.
Master clinical trial methodology: regulations, cost and budget, planning and implementation, risk management, auditing, pharmacovigilance, subcontracting management, etc.
Master all the steps involved in managing a clinical trial database in compliance with regulations and good clinical practice (design of the database based on the protocol and CRF, quality control, programming of data consistency checks, validation plan, coding of adverse events, import of laboratory data, freezing of the database, etc.).
Organization
Open on a sandwich basis
Contract type | Apprenticeship contract, Professionalization contract |
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According to the provisional timetable provided by the course.
Program
M1 trains students to become Clinical Research Associates, and in M2 they can choose one of two sub-courses: Clinical Database Management or Clinical Study Coordination.
Select a program
Master 1 Clinical Operations and Data Management (MODM) - Data Management sub-course
Master 1 Clinical Operations and Data Management (MODM) - Data Management sub-course
Databases - Epidemiology and health environment
5 creditsStrat de Dvpmt prodts de santé - Gestion de prjt et dvpmt clin
5 creditsElective courses Semester 1
5 creditsYour choice: 1 of 4
Regulatory and financial aspects, Quality and safety TC
5 creditsBiotechnologies applied to health
5 creditsModern languages and communication
5 creditsEnglish Semester 1
Modern languages
Choice: 1 of 3
Spanish Semester 1
2.5 creditsGerman Semester 1
2.5 creditsOther language Semester 1
2.5 credits
Documentation and communication
Regulatory Affairs, GCP, Pharmacovigilance
5 creditsInternship
10 creditsClinical trial monitoring and logistics
5 creditsEnglish and 2nd language
5 creditsEnglish Semester 2
2.5 creditsModern languages Choice 2
2.5 creditsChoice: 1 of 3
Introduction to clinical database management
5 credits
Master 2 Clinical Operations Management and Data Management: Data Management Sub-Course
Master 2 Clinical Operations Management and Data Management: Data Management Sub-Course
And then
Bridges and reorientation
other equivalent master's degrees
Professional integration
Jobs associated with clinical research (pharmaceutical industry, CRO, clinical investigation center, public health institution...):
Data Manager (http://www.leem.org/gestionnaire-de-donnees-biomedicales)
Clinical Research Associate (http://www.leem.org/attache-de-recherche-clinique)
Clinical trials coordinator or manager (http://www.leem.org/attache-de-recherche-clinique-manager)