01/03/2019

Clinical Research (Medical Device) Project Manager

This job offer has expired


  • ORGANISATION/COMPANY
    European Clinical Research Infrastructure Network
  • RESEARCH FIELD
    Other
  • RESEARCHER PROFILE
    Established Researcher (R3)
  • APPLICATION DEADLINE
    01/04/2019 00:00 - Europe/Brussels
  • LOCATION
    France › Paris
  • TYPE OF CONTRACT
    Permanent
  • JOB STATUS
    Full-time
  • HOURS PER WEEK
    35
  • OFFER STARTING DATE
    01/05/2019
  • EU RESEARCH FRAMEWORK PROGRAMME
    H2020
  • REFERENCE NUMBER
    ECRIN-MDPM

The Project Manager is responsible for managing projects that are allocated to him/her, either a clinical study, or the development of a new tool for cutting edge multinational clinical studies, with particular focus on medical devices.

The main duties of the ECRIN Project Manager will include the following:

For tool development projects:

  • Contributing to the work packages and task activities ECRIN is responsible for
  • Ensuring that specific pieces of project work under the ECRIN responsibility are implemented and completed successfully in line with planned timelines
  • Contributing to internal and external communication related to the projects
  • Establishing strong interactions with the project partners
  • Working on other duties as assigned

For clinical studies:

  • Coordinating the operational management of ECRIN-supported clinical studies that are assigned to him/her: provision of information, feasibility and risk assessment and organising the provision of distributed, multinational study management services; in particular regulatory and ethical submissions, adverse event reporting, monitoring, data management.
  • Ensuring compliance of ECRIN services with the ECRIN quality management policy.
  • Working closely with investigators and sponsors to adapt ECRIN services to the context of the study and to the funding available
  • Maintaining and updating the database of his/her ECRIN-supported projects
  • Contributing to the development of tools facilitating multinational studies
  • Contributing if required to the training of ECRIN European Correspondents and study staff
  • Contributing to the development and maintenance of the quality management system, in particular as author/editor of SOPs
  • Working on others duties as assigned

Requirements:

  • University degree in Health or Life Sciences (PhD level would be a plus)
  • Experience in multinational clinical research
  • Experience in medical devices clinical research
  • Strong knowledge of the clinical research development process, GCP, local and international regulatory requirements.
  • Knowledge of quality by design.
  • Complementary knowledge of experimental design, statistics and data management is desirable.
  • Extensive experience in project management, in particular EU funded projects (H2020, IMI)
  • Experience in operating at European/international level
  • Excellent organisational skills, and ability in managing tasks across various functions and projects
  • Strong oral and written communication skills
  • Excellent written and spoken English (working language)
  • Team player
  • Computer and software knowledge

 

The post is under the responsibility of the Operations Director. The Project Manager shall work in close collaboration with the ECRIN Management Office in Paris and the national European Correspondents based in the ECRIN member/observer countries.

The post is a full-time contract according to French law. The salary is set according to European/international standards for similar positions, and will depend on qualifications and experience.

Place of employment: Paris, France, where ECRIN has its Management Office and legal address.

A letter of motivation with a Curriculum Vitae (European format with photo) may be addressed to Mrs Alicja Szofer-Araya (alicja.szofer-araya@ecrin.org).

More information on ECRIN at www.ecrin.org

Offer Requirements

  • REQUIRED EDUCATION LEVEL
    Other: Master Degree or equivalent
  • REQUIRED LANGUAGES
    ENGLISH: Excellent

Skills/Qualifications

  • University degree in Health or Life Sciences (PhD level would be a plus)
  • Experience in multinational clinical research
  • Experience in medical devices clinical research
  • Strong knowledge of the clinical research development process, GCP, local and international regulatory requirements.
  • Knowledge of quality by design.
  • Complementary knowledge of experimental design, statistics and data management is desirable.
  • Extensive experience in project management, in particular EU funded projects (H2020, IMI)
  • Experience in operating at European/international level
  • Excellent organisational skills, and ability in managing tasks across various functions and projects
  • Strong oral and written communication skills
  • Excellent written and spoken English (working language)
  • Team player
  • Computer and software knowledge

Work location(s)
1 position(s) available at
European Clinical Research Infrastructure Network
France
Paris
75013
5-7 rue Watt

EURAXESS offer ID: 384412

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