ECTS
120 credits
Duration
2 years
Training structure
School of Pharmacy
Language(s) of instruction
French
Presentation
The program provides dual expertise in the fields of clinical research and project management. It trains executives specializing in clinical research: Clinical Research Associates and International Clinical Study Coordinators.
90%
Success rate
The advantages of the training program
Objectives
The objective is to train executives specializing in the field of Clinical Research Associate (CRA) in Master 1. The training is completed in Master 2 with Project Management to qualify for the position of International Clinical Study Coordinator. It is carried out on a work-study basis in large pharmaceutical companies.
Know-how and skills
- Mastering Project Management: planning, cost management, deadlines, risks
- Develop, coordinate, monitor, and implement clinical studies
- Knowing how to conduct a feasibility study
- Mastering international regulations (ICH, FDA, CTD, etc.).
- Know the standard procedures
- Ensuring compliance, quality, and data management
- Understanding the statistical methodology of clinical trials
- Managing adverse events, pharmacovigilance
- Knowing how to write a clinical study report according to ICH guidelines
- Managing subcontracting in the sponsor-CRO relationship
- Respecting ethics in clinical trials
Organization
Open alternately
Type of contract | Apprenticeship contract, Professional training contract |
|---|
According to the provisional schedule provided by the training program.
Internships, supervised projects
Internship | Mandatory |
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Duration of the internship | Master 1: 3 to 5 months / Master 2: 4 to 6 months |
Internship abroad | Possible |
Internships in public or private institutions:
Projects supervised by professionals in M1 and M2
Program
- Educational Space for 3D Printing in Healthcare. Learning Lab, flipped classroom, interactive seminars, company visits, project-based learning, etc.
- Numerous external professional contributors
- M1 + M2 open to apprenticeships, schedules adapted to optimize practical training
Select a program
Master 1 Clinical Operations Management and Data Management - Clinical Operations track
Master 1 Clinical Operations Management and Data Management - Clinical Operations 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 2 Clinical Operations Management and Data Management - Clinical Operations track
Master 2 Clinical Operations Management and Data Management - Clinical Operations sub-program