Health

Master 1 Clinical Operations Management and Data Management - Clinical Operations track

  • ECTS

    60 credits

  • Duration

    1 year

  • Training structure

    School of Pharmacy

  • Language(s) of instruction

    French

Presentation

Master 1 Clinical Operations Management and Data Management - Clinical Operations track

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  • 100% success rate in the 2021-2022 exams

    Success rate

The advantages of the training program

Organization

Knowledge assessment

 Master's 1

  • Therapeutic approaches
  • Clinical trial monitoring and logistics:
    -Regulatory environment, preclinical dossier, clinical dossier
  • Essential ICH documents for conducting trials (before, during, and at the end of the trial).
  • Introduction to Clinical Database Management, CDISC Standards.
  • Medical writing according to the ICH

 

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Open alternately

Type of contract

Professional training contract, Apprenticeship contract

According to the provisional schedule provided by the training program. 

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Internships, supervised projects

Internship

Mandatory

Duration of the internship

3 to 5 months

Internship abroad

Possible

Program

  • 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

Admission

Admission requirements