Health

Clinical Operations and Data Management (MODM) – Clinical Operations Track

  • ECTS

    120 credits

  • Duration

    2 years

  • Training Structure

    School of Pharmacy

  • Language(s) of Instruction

    French

Overview

The program provides dual expertise in the fields of clinical research and project management. It trains professionals specializing in clinical research: Clinical Research Associate and International Clinical Trials Coordinator.

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  • 90%

    Success Rate

The Benefits of the Training Program

Objectives

The goal is to train professionals specializing in the role of Clinical Research Associate (CRA) during the first year of the master’s program. The program is supplemented in the second year with coursework in project management to prepare students for a career as an International Clinical Trials Coordinator. It is delivered through a work-study program at major pharmaceutical companies.

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Expertise and Skills

  • Mastering Project Management: Planning, Cost Management, Schedule Management, and Risk Management
  • Develop, coordinate, monitor, and conduct clinical trials
  • How to Conduct a Feasibility Study
  • Have a thorough understanding of international regulations (ICH, FDA, CTD, etc.).
  • Be familiar with standard procedures
  • Ensure compliance, quality, and data management
  • Understanding the Statistical Methodology of Clinical Trials
  • Managing Adverse Events, Pharmacovigilance
  • How to Write a Clinical Study Report in Accordance with ICH Guidelines
  • Managing Outsourcing in the Developer-CRO Relationship
  • Adhering to Ethical Standards in Clinical Trials
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Organization

Open on an alternating basis

Contract Type

Apprenticeship Contract, Professional Training Contract

According to the tentative schedule provided by the class. 

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Internships, supervised projects

Internship

Required

Duration of the internship

Master's Year 1: 3 to 5 months / Master's Year 2: 4 to 6 months

Internship Abroad

Possible

Internships at public or private institutions:

Projects supervised by professionals in the M1 and M2 programs

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Program

  • Educational Hub for 3D Printing in Healthcare. Learning Lab, flipped classroom, interactive seminars, company visits, project-based learning…
  • Numerous external professionals
  • M1 and M2 programs are open to apprentices; schedules are tailored to optimize hands-on training
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Select a program

Master's 1 in Clinical Operations and Data Management - Clinical Operations Track

Master's 1 in Clinical Operations and Data Management - Clinical Operations Track

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  • Databases – Epidemiology and Environmental Health

    5 credits
    • Epidemiology and Environmental Health

    • Database

      • Written Database

      • Mini Project Database

  • Healthcare Product Development Strategy – Project Management and Clinical Development

    5 credits
    • CC Health Products Development Strategy

    • Health Product Development Strategy EC

  • Elective Courses, Semester 1

    5 credits
    • Choose 1 of 4

      • Therapeutic Areas - Pharmacokinetics - PEC

        5 credits
      • Scientific and Technical Foundations of Polymer Biomaterials

        5 credits
        • Scientific and Technical Foundations of Biomaterials: Lab Session

        • Scientific and Technical Foundations of Biomaterials: Written Text

      • Corporate Risk Management from the Perspectives of the DRT, the ECO, and the ENVT

        5 credits
        • Corporate Risk Management: Written/Oral

        • Corporate Risk Management Written

      • Physicochemistry of Health Product Formulation

        5 credits
        • Physicochemistry of Health Product Formulation EC/CC

        • Physicochemistry of Health Product Formulation: Written Exam

  • Regulatory and Financial Aspects, Quality and Safety TC

    5 credits
    • Pharmaceutical Law

    • Regulatory Issues (Written)

      • Financial Analysis

      • Security

      • Quality

      • Marketing

  • Biotechnology Applied to Healthcare

    5 credits
    • Biotechnology Applied to Healthcare CC

    • Biotechnology Applied to Health Written

  • Modern Languages and Communication

    5 credits
    • English, Semester 1

    • Modern Languages

      • Choose 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
    • Company Internship Report

    • Oral Business Internship

    • Company Internship Evaluation

  • Clinical Trial Monitoring and Logistics

    5 credits
    • Monitoring and Logistics

    • Hospital Internship

      • Oral Hospital Internship

      • Hospital Internship Evaluation

      • Hospital Internship Report

  • English and a Second Language

    5 credits
    • English, Semester 2

      2.5 credits
    • Modern Languages, Option 2

      2.5 credits
      • Choose 1 of 3

        • Other Language, Semester 2

          2.5 credits
        • German, Semester 2

        • Spanish, Semester 2

  • Introduction to Clinical Database Management

    5 credits
    • SAS

      • Practical SAS

      • SAS Project

    • Data

      • Project Data

      • Date Written

Master 2 in Clinical Operations Management and Data Management - Clinical Operations Track

 Master 2 in Clinical Operations Management and Data Management - Clinical Operations Track 

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  • M2 Cross-Curricular Courses

    • Project Management, Healthcare Products, Management Control, Oversight

      5 credits
      • Healthcare Product Project Management (Written)

      • Healthcare Product Project Management - Project

    • Quality Management, Marketing, Team Management

      5 credits
      • Quality Management, Marketing, Team Management (Multiple-Choice Questions)

      • Quality Management, Marketing, Team Management (Written)

  • Master 2 Course: MODM-OPC Track

    • OPC Project-Based Learning

      2.5 credits
    • Biomedical Data Management

      2.5 credits
    • Clinical Operations Management

      5 credits
      • Clinical Operations Management (Written)

      • Clinical Operations Management Project

    • Project Management for Healthcare Products

      5 credits
    • Regulatory Affairs—Pharmacovigilance, Marketing

      5 credits
      • Regulatory Affairs—Pharmacovigilance, Marketing Written

      • Regulatory Affairs—Pharmacovigilance, Marketing Project

  • Internship

    20 credits
    • Internship Report

    • Oral Presentation on a Company Internship

    • Company Internship Evaluation

  • Master's 2, Semester 4, MODM-OPC Track

    • Project-Based Learning

      5 credits
    • Specific clinical trials

      2.5 credits
      • Specific Clinical Trials Written

      • Specific Clinical Trials Project

    • Clinical Data Analysis and Management Tools

      2.5 credits
      • Tools for Clinical Data Analysis and Management Written

      • Clinical Data Analysis and Management Tools Project

Admission

Target Audience

Bachelor's Degree in Biology and Health
Bachelor's Degree in Health Engineering
Continuing Education
pharmacy and medical students

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Mandatory Prerequisites

Bachelor's Degree in Science

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Recommended Prerequisites

Good command of English

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And then

Transition Programs and Reorientation

other equivalent master's degrees

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Employment Placement

ARC, ARC Manager | Clinical Trial Coordinator | Clinical Trial Manager | Clinical Project Manager

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