Clinical Trial Officer

We are looking for an CTA Officer to take care of our existing projects which would include the following responsibilities:

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 :

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

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