Mes compétences :
financial agreements preparation
Preparation and negotiation of financial agreement
Microsoft Word
Microsoft PowerPoint
Microsoft Excel
Global coordination
GCP
Feasibility Studies
Entreprises
Quintiles
- Regulatoy and Start-up lead
Durham2014 - maintenant
Quintiles
- Regulatory and Start-up lead
Durham2014 - maintenantQuintiles - Regulatory and Start-up lead. Coordination of start-up activities accross
Middle east countries.
Key contact to Sponsors & local teams for start-up activities. Overview and coordination of country
submissions (ECs/RAs and any local submissions) + financial agreements preparation. Coordination
of IP release processes. Trainings to local teams.
Quintiles
- Senior Regulatory Start-Up Specialist
Durham2011 - 2013EC (CPP) / RA (ANSM) / CNOM submissions (initial + amendments)
Preparation and negotiation of financial agreement templates and budgets.
Expertise on French start-up processes - delivery of trainings
i3 Research
- Clinical Research Associate
2009 - 2011* Study start up activities : feasibility studies, review and validation of French submission
essential documents, collection and review of investigators essentials documents prior to site
initiation, submissions (CPP, AFSSAPS, CNOM), Preparation and negotiation of financial
agreement templates and budgets with investigators and institutions
* Routine site visits including pre-study, monitoring and close out visits
La Defense2008 - 2008CRA professional training Institut Léonard de Vinci & Groupement d'Ecoles des métiers de la
regulatory aspects of biomedical research, good clinical practices (GCP)
