Clinical Research Director Pneumology – France

Excelya>All job opportunites>Full-time, Permanent Contract>Clinical Research Director Pneumology – France

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

  • Document writing: abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments related to the assigned clinical trials in the field of clinical development in Pneumology.
    • Medical support for real world data pressure test and for operational feasibility
    • Contribution to answers to HAs, ECs, clinical sites and study team (global and locals)
    • Participation and preparation to various meetings (investigators, monitors, etc.)
    • Contribution to management of committees
    • Medical support and guidance to (and training of) team (CSO PL, GSM, biostatistician, Medical Advisors, CPLs/etc), CRO and investigators
    • Medical input on study plans (CMP, MRP, DR & DS review and SRMP), CRF, CRF completion instructions, deviation list
    • Medical support and guidance to data review, statistical surveillance, coding, medical validation and Clinical case review material development
    • Clinical Case review on patient profiles, review and validation of narratives
    • Statistical Analysis Plan review and endorsement
    • Contribution to Key Result Preparation
    • Clinical Study Report development (drafting of specific sections, review)
    • Review of draft publications
    • Preparation of audits and inspections

Minimum Requirements :

Doctor of Medicine

Around ten years’ experience in the pharmaceutical industry

You have significant experience in clinical research, particularly in the following pathologies: Pneumology

Bilingual in English

The position can be done remotely 



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