Clinical Research Director

Description du poste et des missions

I. EXCELYA

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 900 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 journ 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.

II. Mission

• Document writing : abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments related to the assigned complex / pivotal clinical trials in the field of clinical development in immunology and Inflammation.


•  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:


• Steering Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.


• Data Monitoring Committee (DMC): contact with selected members, Set-up, Charter development, meetings, reporting and documentation.


• Adjudication Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.


• Medical input on study plans (CMP, MRP, SS review and SRMP), CRF, CRF completion instructions, deviation list and management.


• Medical support and guidance to data review, statistical surveillance, coding, medical validation and Clinical case review material development


• Clinical Case review (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)


• Preparation in anticipation and answers to Audits and inspections


• Review of draft publications, (Support to publications)


• Preparation of audits and inspections


• Support to submission and clinical development plan

Profil souhaité

You have an experience in the private sector (labs or CROs) and a medical degree (French or European preferred). You contributed to clinical trial design, medical data review (patient profiles, clinical cases review), participation in various monitoring committees (PV), DMC (Data monitoring committee), participation in study documents, guarantee of medical responses to authorities.

Lieu de la mission