Chef De Projet Epidemiologie-Pharmacoepidemiologie

Chef De Projet Epidemiologie-Pharmacoepidemiologie

Qualees is a human-sized CRO specialized in conducting studies in epidemiology, pharmaco-epidemiology (RIPH 2 and 3 and non-RIPH) and health economics. We work both on behalf of the pharmaceutical industry, as well as for public and associative structures.

Your mission will be to manage the operational aspects of the studies conducted by Qualees. You will ensure the operational management and follow-up of ongoing projects, from their methodological conception to the presentation of the results.

You will manage the various internal and external stakeholders to ensure the smooth running of the project. You will work in compliance with internal procedures and applicable regulations, and you will take responsibility for the key processes related to the conduct and delivery of a service compliant with the regulations and the expectations of Qualees and its clients.

You will ensure permanent reporting and interface with clients, and you will ensure compliance with the terms of reference.

Your main tasks will be the following:

• coordination and participation in the preparation of study-related documents (study proposal, protocol, questionnaires, statistical analysis plan)
• completion of administrative and regulatory procedures related to studies
• completion of study kits, supervision of the development of e-CRF and monitoring databases
• planning, coordination and follow-up of the 'field' phase of studies (recruitment, management of agreements, setup, and monitoring of centers)
• management of pharmacovigilance / cosmetovigilance / materiavigilance
• coordination and participation in the data management stages
• coordination and participation in the preparation of study results documents (analysis report, publications, abstracts and posters)
• regular transmissions of the state of progress of projects and studies to concerned clients.

Education: higher scientific education (minimum bac+5)

Required Skills: operational English

Required Qualities: rigor, quality of writing, autonomy.

- significant experience of at least 3 years in a similar position within a CRO, in which you have developed your scientific expertise and operational management of this type of studies.

- mastery of studies carried out from the SNDS

Name and Surname:
Philippe Caroline Email address:

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