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)