Activities and Responsibilities:

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


For EU : management of submission through CTIS according to New regulation and management of transition of studies from Directive to New Regulation.


Coordinator Back-up (quality check of dossier, support to prepare/review the process / SOP / WPD (Working Practice documents)

Required education:

Scientific background

Required experience :

5 to 10 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


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

197 CTA Specialist