Health

Clinical Operations Management and Data Management (MODM) Data Management specialization

  • 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.

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Objectives

Train engineers in the field of health and clinical research

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Know-how and skills

Double competence in clinical research and project management.
Master the tools necessary for the management of clinical trials, master the tools of project management, master the risks associated with the realization of clinical trials.
Master the methodology of clinical trials: regulations, cost and budget, planning and implementation, risk management, audit, pharmacovigilance, management of subcontracting, ...
To master all the steps involved in managing a clinical trial database in compliance with regulations and good clinical practices (design of the database based on the protocol and CRF, quality control, programming of data consistency checks, validation plan, coding of adverse events, importing laboratory data, freezing the database, etc.)

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Organization

Open in alternation

Type of contract

Apprenticeship contract, Professionalization contract

According to the provisional calendar provided by the course. 

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Program

The M1 program trains students to become Clinical Research Associates, and then in M2 students choose one of the two sub-courses: Clinical Database Management or Clinical Study Coordination.

 

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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

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  • Databases - Epidemiology and health environment

    5 credits

    • Epidemiology and health environment

    • Data base

      • 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 of 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 in a company

    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 of 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: Data Management Subcourse

Master 2 Clinical Operations and Data Management: Data Management Subcourse

See the complete page of this course

  • Master 2 UE MODM-GDC course

    • Biomedical data management

      2.5 credits

    • Database management - Programming

      10 credits

      • SQL-R Practical Exam

      • SAS Practical test

    • Data Management 1

      7.5 credits

      • Data Management 1 Written

      • Data Management 1 Report

  • 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

  • Internship in a company

    20 credits

    • Internship Report

    • Internship Oral

    • Internship Appreciation

  • Master 2 Semester 4 MODM-GDC pathway

    • Project-based learning GDC

      5 credits

      • Project-based learning GDC Report

      • Project-based learning GDC Oral

    • Data Management 2

      5 credits

      • Data Management 2 Moodle written exam

      • Data Management 2 Group work

Admission

Target audience

Bachelor's degree in Biology and Health
Bachelor's degree in Health Engineering
Continuing education
students in pharmacy, medicine 

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Necessary pre-requisites

Scientific degree level

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Recommended prerequisites

Good level of English

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And then

Bridges and reorientation

other equivalent masters

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Professional integration

Jobs associated with clinical research (pharmaceutical industry, CRO, clinical investigation center, public health institution...):
Clinical database 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)

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