Responsibility:
Operational Activity:
Preparation and submission of CTA in EU and outside of EU from initial CTA preparation until notification of results
Review of documents (clinical study protocol, Informed consent form, …)
Capacity to provide the technical/practical regulatory expertise on the documents and on submission strategy
Coordinator Back-up
Required education:
Scientific background
Required experience :
3 to 5 years
Required languages:
French if possible
Required technical skills:
Good overview of Clinical Trials environment
Skills of Clinical Trials regulation
CTA management through CTIS / Transition management
Experience in coordination of team
Word/excel/powerpoint
Meeting management
Additional experience and/or skills:
eTMF : Veeva
Force of proposal, good analysis of situation, proactivity
Good relationship
A plus if skills for the following countries: Japan, China, US, Canada
- Capacity to manage multiple activities in same time