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:
You will be responsible for :
- 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 oncology.
- 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 support and guidance to (and training of) the 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)
- Preparation in anticipation and answers to Audits and inspections
- Review of draft publications
- Preparation of audits and inspections