Clinical Trial Officer

4 weeks ago

Kannur, India ProductLife Group Full time

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

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