ECTS
120 credits
Duration
2 years
Training Structure
School of Pharmacy
Language(s) of Instruction
French
Overview
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. Specialization at the Master 2 level.
Objectives
Training engineers in the fields of healthcare and clinical research
Expertise and Skills
Expertise in both clinical research and project management.
Master the tools necessary for managing clinical trials, master project management tools, and manage the risks associated with conducting clinical trials.
Master clinical trial methodology: regulations, costs and budgeting, planning and implementation, risk management, auditing, pharmacovigilance, subcontractor management, etc.
Master all stages of managing a clinical trial database in compliance with regulations and good clinical practices (database design based on the protocol and CRF, quality control, scheduling of data consistency checks, validation plan, coding of adverse events, importing laboratory data, database freeze, etc.)
Organization
Open on an alternating basis
Contract Type | Apprenticeship Contract, Professional Training Contract |
|---|
According to the tentative schedule provided by the class.
Program
The M1 program trains students to become Clinical Research Associates; students then choose one of two specializations for the M2: Clinical Database Management or Clinical Trial Coordination.
Select a program
Master 1 in Clinical Operations Management and Data Management (MODM) - Data Management Track
Master 1 in Clinical Operations Management and Data Management (MODM) - Data Management Track
Databases – Epidemiology and Environmental Health
5 creditsHealthcare Product Development Strategy – Project Management and Clinical Development
5 creditsElective Courses, Semester 1
5 creditsRegulatory and Financial Aspects, Quality and Safety TC
5 creditsBiotechnology Applied to Healthcare
5 creditsModern Languages and Communication
5 creditsEnglish, Semester 1
Modern Languages
Choose 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 a Second Language
5 creditsEnglish, Semester 2
2.5 creditsModern Languages, Option 2
2.5 creditsChoose 1 of 3
Introduction to Clinical Database Management
5 credits
Master's Degree (Year 2) in Clinical Operations Management and Data Management: Data Management Track
Master's Degree (Year 2) in Clinical Operations Management and Data Management: Data Management Track
And then
Transition Programs and Reorientation
other equivalent master's degrees
Employment Placement
Jobs related to clinical research (pharmaceutical industry, CROs, clinical research sites, public health institutions, etc.):
Clinical Database Manager (Data Manager) (http://www.leem.org/gestionnaire-de-donnees-biomedicales)
http://www.leem.org/attache-de-recherche-clinique
Clinical Trial Coordinator or Manager (http://www.leem.org/attache-de-recherche-clinique-manager)