Study Start Up Specialist

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:

Within the SSU team, and in collaboration with the other regulatory managers and clinical trial project leaders you will be responsible for:
– Constitute, submit, and follow up on clinical trial opinion and authorization request files with the ANSM and the Personal Protection Committees (CPP)
– Participate in meetings of the EC support team and project teams for the coordination of CPP and ANSM activities
– Report to global and local teams, and update support tracking software


Minimum Requirements :

  • Extensive experience in a pharmaceutical laboratory preparing and submitting dossiers to CPP and ANSM for interventional research,
  • In-depth knowledge of the Experimental Drug File for the ANSM file
  • Knowledge of the regulations related to EC and corresponding systems (EUDRALINK …),
  • Team spirit, rigor, multi-project work.
  • Fluent English



Apply for this job

Similar career opportunities


  • Paris Area
  • February 16, 2023

Clinical Scientist

  • Paris Area
  • February 16, 2023