Health

Clinical Operations Management and Data Management (MODM) Sub-track Data Management

  • ECTS

    120 credits

  • Duration

    2 years

  • Training structure

    School of Pharmacy

  • Language(s) of instruction

    French

Presentation

The aim is to train executives specializing in clinical data management and promote their rapid employability through academic and work-study training using active teaching methods. Specialization in Master 2.

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Objectives

Training engineers in the field of health and clinical research

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Know-how and skills

Dual expertise in clinical research and project management.
Mastery of the tools required for clinical trial management, project management tools, and the risks associated with conducting clinical trials.
Mastery of clinical trial methodology: regulations, cost and budget, planning and implementation, risk management, auditing, pharmacovigilance, subcontractor management, etc.  
Master all stages of managing a clinical trial database in accordance with regulations and good clinical practices (designing the database based on the protocol and CRF, quality control, programming data consistency checks, validation plan, coding adverse events, importing laboratory data, database freeze, etc.).)

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Organization

Open alternately

Type of contract

Apprenticeship contract, Professional training contract

According to the provisional schedule provided by the training program. 

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Program

The M1 trains students for the profession of Clinical Research Associate, then in the M2 students choose one of two sub-specializations: Clinical Database Management or Clinical Study Coordination.

 

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Select a program

Master 1 Clinical Operations Management and Data Management (MODM) - Data Management track

Master 1 Clinical Operations Management and Data Management (MODM) - Data Management track

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  • Databases – Epidemiology and Environmental Health

    5 credits
    • Epidemiology and health environment

    • Database

      • Written database

      • Mini Project Database

  • Healthcare Product Development Team – Project Management and Clinical Development

    5 credits
    • Health product development strategy CC

    • Health product development strategy EC

  • Elective EU Semester 1

    5 credits
    • Choose 1 out of 4

      • Therapeutic approaches - Pharmacokinetics - PEC

        5 credits
      • Scientific and technical fundamentals of polymeric biomaterials

        5 credits
        • Scientific and technical foundations of biomaterials TP

        • Scientific and technical foundations of biomaterials Written

      • Risk management as seen by IT security, economics, and the environment

        5 credits
        • Business risk management Written/Oral

        • Enterprise 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

      • Safety

      • Quality

      • Marketing

  • Biotechnology applied to health

    5 credits
    • Biotechnology applied to health CC

    • Biotechnology applied to health Written

  • Modern Languages and Communication

    5 credits
    • English Semester 1

    • Modern languages

      • Choose 1 out 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, BPC, Pharmacovigilance

    5 credits
    • Regulatory Affairs, BPC, Pharmacovigilance Project

    • Regulatory Affairs, BPC, Pharmacovigilance Written

  • Internship

    10 credits
    • Company internship Report

    • Oral business internship

    • Internship Appraisal

  • Monitoring and logistics of clinical studies

    5 credits
    • Monitoring and logistics

    • Hospital internship

      • Hospital internship Oral

      • Hospital internship Assessment

      • Hospital internship Report

  • English and second language

    5 credits
    • English Semester 2

      2.5 credits
    • Modern languages Choice 2

      2.5 credits
      • Choose 1 out of 3

        • Other language Semester 2

          2.5 credits
        • German Semester 2

        • Spanish Semester 2

  • Introduction to clinical database management

    5 credits
    • SAS

      • SAS Practice

      • SAS Project

    • Data

      • Data Project

      • Data Written

Master's Degree in Clinical Operations Management and Data Management: Data Management Track

Master's Degree in Clinical Operations Management and Data Management: Data Management Track

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  • Master 2 EU MODM-GDC Course

    • Biomedical data management

      2.5 credits
    • Database management - Programming

      10 credits
      • SQL-R Practical Exam

      • SAS Practical Exam

    • Data Management 1

      7.5 credits
      • Data Management 1 Written

      • Data Management 1 Report

  • M2 Cross-disciplinary EU

    • Project management Health products Management control Steering

      5 credits
      • Healthcare Product Project Management Written

      • Health Products Project Management - Project

    • Quality management, Marketing, Team management

      5 credits
      • Quality management, marketing, QCM team management

      • Quality management, Marketing, Team management Written

  • Internship

    20 credits
    • Internship Report

    • Oral internship

    • Internship Appraisal

  • Master's Degree, Semester 4, MODM-GDC Track

    • GDC Project-Based Learning

      5 credits
      • Project-based learning GDC Report

      • Project-based learning GDC Oral

    • Data Management 2

      5 credits
      • Data Management 2 Written moodle

      • Data Management 2 Group work

Admission

Target audience

Bachelor's Degree in Biology and Health
Bachelor's Degree in Health Engineering
Continuing education
Pharmacy and medicine students 

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Mandatory prerequisites

Bachelor's degree in science

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Recommended prerequisites

Good level of English

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And after

Gateways and reorientation

other equivalent master's degrees

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Professional integration

Jobs related to clinical research (pharmaceutical industry, CRO, clinical investigation center, public health institution, etc.):
Clinical database manager (Data 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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