SDEA Safety project manager – France

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:

• Replying to e-mails from the platforms on case management,
• Monitoring case processing times, identifying the reasons for delays in reporting/transmitting cases…..,
• Participating in weekly quality control of case processing (data entry, coding, narrative writing) on the platforms, including medical review of cases:
• Editing listings and checking data against source documents and overall consistency of data,
• Provision of listings with corrections or requests for clarification in the platforms’ SharePoint,
• Checking the response from the platforms and the corrections or requests for clarification made,
• Signing off on quality control.
• Participating in the quality control of the clinical study case narratives provided by the platforms for inclusion in the clinical study report,
• Participation in supervising the reconciliation of pharmacovigilance cases with partners (SDEA) and cases with the clinical database outsourced to the platforms.