Health

Clinical Operations and Data Management (MODM)

  • ECTS

    120 credits

  • Duration

    2 years

  • Training structure

    Faculty of Pharmacy

Presentation

The course trains managers specialised in data management of clinical studies and in the coordination of clinical trials.

It is organised into two sub-courses Clinical Database Management and Clinical Study Coordination.

  • The course provides an initial competence in the field of logistics and management of clinical studies, corresponding to the knowledge required for the job of Clinical Research Associate (CRA) in the pharmaceutical industry. The scientific and technological training acquired in M1 is completed by giving the double competence in Project Management necessary for the national and international coordination of clinical studies in the respect of regulations and deadlines: administrative, regulatory and budgetary management, selection and management of subcontractors, allocation and reallocation of budgetary and human resources, monitoring of the good progress of clinical studies  
  • It also allows students to specialise in Biomedical Data Management; all the stages of Clinical Data Management are taught: study protocol, observation book (CRF, e-CRF), database structure, validation plan, control and consistency tests, audit trail, blind-review, regulatory environment and SOP, freezing of base, archiving. The practical part is carried out with CLINTRIAL, ORACLE CLINICAL, Oracle SQL programming, PL/SQL and SAS software The teaching of data management is supported by professional data managers and the international association Biomedical Data Management (see http://www.dmb-asso.org).
  • The practical parts are carried out in the form of case studies: implementation of projects to launch a new clinical study. The subjects are real-life situations proposed by clinical research professionals from the pharmaceutical industry, international clinical study coordinators, clinical study managers, data managers.
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  • 90%

    Success rate

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.
To master the tools necessary for the management of clinical trials, to master project management tools, to master the risks associated with the conduct of clinical trials.
To master the methodology of clinical trials: regulations, cost and budget, planning and implementation, risk management, auditing, pharmacovigilance, management of subcontractors, etc.
Master all the steps of the management of a clinical trial database in compliance with the regulations and the good clinical practices (design of the database from the protocol and the CRF, quality control, programming of data consistency checks, validation plan, coding of adverse events, import of laboratory data, freezing of the database...)

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Organization

Special facilities

alternation possible in the sub-course Clinical Study Coordination in M2

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Programme

M1 trains students for the job of Clinical Research Associate, and then in M2 they choose one of the two sub-courses: Clinical Database Management or Clinical Study Coordination.

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Select a programme

M1 Clinical Operations Management and Data Management

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M2 Clinical Operations and Data Management

The MODM course "Clinical Operations Management and Data Management" will have two sub-courses:

- OPC: Clinical Operations

- GDG: Clinical Data Management

For the OPC sub-course: new contents complete the training: introduction to ethics in clinical trials, Lean Management in trial coordination, new perspectives for clinical trial management brought by new digital technologies, developments in national, European and international regulations in clinical trials.

For the CDM sub-course: Opening of the Clinical Data Management course to learning and change of the students' professional working tool to a more up-to-date EdC tool provided by the owner, and introduction of the programming language R instead of PL/SQL. The content has not changed fundamentally, but some courses have been merged.

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Admission

Target audience

Licence Biologie-Santé
Licence Ingénierie de la Santé
Formation continue
students in pharmacy, medicine

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Necessary pre-requisites

Bachelor of Science level

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Recommended prerequisites

Good level of English

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And then

Gateways and reorientation

other equivalent masters

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Professional integration

Jobs associated with clinical research (pharmaceutical industry, CRO, clinical investigation centre, public health institution, etc.):
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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