Health

Clinical Operations and Data Management (MODM) Clinical Operations sub-course

  • ECTS

    120 credits

  • Duration

    2 years

  • Training structure

    Faculty of Pharmacy

  • Language(s) of instruction

    French

Presentation

The program provides dual skills in clinical research and project management. It trains managers specialized in clinical research: Clinical Research Associate, International Clinical Studies Coordinator.

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  • 90%

    Success rates

Objectives

The aim is to train managers specialized in Clinical Research Associates (CRAs) in Master 1. In Master 2, the course is rounded off with Project Management to qualify for the position of International Clinical Studies Coordinator. Work-study placements are available with major pharmaceutical companies.

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Know-how and skills

  • Project management: planning, managing costs, deadlines and risks
  • Design, coordinate, monitor and implement clinical studies
  • Conducting a feasibility study
  • International regulations (ICH, FDA, CTD, etc.).
  • Knowing standard procedures
  • Ensure data compliance, quality and management
  • Understanding the statistical methodology of clinical trials
  • Managing adverse events, pharmacovigilance
  • How to write an ICH clinical study report
  • Managing subcontracting in the developer-CRO relationship
  • Respecting ethics in clinical trials
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Organization

Open on a sandwich basis

Contract type

Apprenticeship contract, Professionalization contract

According to the provisional timetable provided by the course. 

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Internships, tutored projects

Internship

Mandatory

Length of internship

Master 1: 3 to 5 months / Master 2: 4 to 6 months

Internship abroad

Possible

Internships in public or private institutions:

Projects tutored by professionals in M1 and M2

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Program

  • Educational space for 3D printing in healthcare. Learning Lab, flipped courses, interactive seminars, company visits, project-based learning...
  • Numerous professional guest speakers
  • M1 + M2 open to apprenticeships, schedules adapted to optimize practical training
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Select a program

Master 1 Clinical Operations and Data Management - Clinical Operations sub-course

Master 1 Clinical Operations and Data Management - Clinical Operations sub-course

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  • Databases - Epidemiology and health environment

    5 credits

    • Epidemiology and health environment

    • Database

      • Database Written

      • Mini Project database

  • Strat de Dvpmt prodts de santé - Gestion de prjt et dvpmt clin

    5 credits

    • Healthcare product development strategy CC

    • Health product development strategy EC

  • Elective courses Semester 1

    5 credits

    • Your choice: 1 of 4

      • Therapeutic areas - Pharmacokinetics - PEC

        5 credits

      • Scientific and technical foundations of polymer biomaterials

        5 credits

        • Scientific and technical bases of biomaterials TP

        • Scientific and technical bases of biomaterials Written

      • Enterprise risk management as seen by drt, ec and envt

        5 credits

        • Business risk management Written/Oral

        • Business risk management Written

      • Physicochemistry of health product formulation

        5 credits

        • Physicochemistry of health product formulation EC/CC

        • Physicochemistry of health product formulation Written

  • Regulatory and financial aspects, Quality and safety TC

    5 credits

    • Pharmaceutical Law

    • Regulatory aspects Written

      • Financial analysis

      • Security

      • Quality

      • Marketing

  • Biotechnologies applied to health

    5 credits

    • Biotechnologies applied to health CC

    • Biotechnologies applied to health Written

  • Modern languages and communication

    5 credits

    • English Semester 1

    • Modern languages

      • Choice: 1 of 3

        • Spanish Semester 1

          2.5 credits

        • German Semester 1

          2.5 credits

        • Other language Semester 1

          2.5 credits

    • Documentation and communication

  • Regulatory Affairs, GCP, Pharmacovigilance

    5 credits

    • Regulatory Affairs, GCP, Pharmacovigilance Project

    • Regulatory Affairs, GCP, Pharmacovigilance Written

  • Internship

    10 credits

    • Internship Report

    • Internship Oral

    • Internship Appreciation

  • Clinical trial monitoring and logistics

    5 credits

    • Monitoring and logistics

    • Hospital internship

      • Hospital internship Oral

      • Hospital internship Assessment

      • Hospital internship Report

  • English and 2nd language

    5 credits

    • English Semester 2

      2.5 credits

    • Modern languages Choice 2

      2.5 credits

      • Choice: 1 of 3

        • Other language Semester 2

          2.5 credits

        • German Semester 2

        • Spanish Semester 2

  • Introduction to clinical database management

    5 credits

    • SAS

      • SAS Pratique

      • SAS Project

    • Data

      • Data Project

      • Data Written

Master 2 Clinical Operations and Data Management - Clinical Operations sub-course

 Master 2 Clinical Operations and Data Management - Clinical Operations sub-course 

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  • M2 Cross-disciplinary courses

    • Project Management Health Products Controlling Steering

      5 credits

      • Health products project management Written

      • Health Products Project Management - Project

    • Quality management, marketing, team management

      5 credits

      • Quality Management, Marketing, Team Management QCM

      • Quality management, marketing, team management Written

  • Master 2 UE MODM-OPC pathway

    • Project-based learning OPC

      2.5 credits

    • Biomedical data management

      2.5 credits

    • Clinical Operations Management

      5 credits

      • Clinical Operations Management Written

      • Clinical Operations Management Project

    • Health products project management

      5 credits

    • Regulatory Affairs-Pharmacovigilance, Marketing

      5 credits

      • Regulatory Affairs-Pharmacovigilance, Written Marketing

      • Regulatory Affairs-Pharmacovigilance, Project Marketing

  • Internship

    20 credits

    • Internship Report

    • Internship Oral

    • Internship Appreciation

  • Master 2 Semester 4 MODM-OPC course

    • Project-based learning

      5 credits

    • Specific clinical trials

      2.5 credits

      • Specific clinical trials Written

      • Specific clinical trials Project

    • Clinical data management and analysis tools

      2.5 credits

      • Clinical data analysis and management tools Written

      • Clinical data analysis and management tools Project

Admission

Target audience

Licence Biologie-Santé
Licence Ingénierie de la Santé
Continuing education
students in pharmacy, medicine

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Necessary prerequisites

Science degree level

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Recommended prerequisites

Good level of English

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And then

Bridges and reorientation

other equivalent master's degrees

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Professional integration

ARC, ARC MANAGER I CLINICAL STUDIES COORDINATOR I CLINICAL STUDIES MANAGER I CLINICAL PROJECTS MANAGER

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