Ref #: 29184

Employment type: Permanent - Full-Time

Location: Hungary

Posted: 13-May-2021

Description

Looking for a Sr Study Start Up person who has experience in managing applications for study approvals to the country Health Authority and also central ethics committee. This is due to the changing process in the way European Union trials will be conducted in future. Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation. The European Medicines Agency (EMA) will set up and maintain CTIS, in collaboration with the Member States and the European Commission
Requirement:
Relevant Study start UP working experience in Clinical Research in strong experience in submission
BSC Degree, Native Hungarian, Hungarian citizenship