Management of regulatory start-up activities under CTR. Independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards.Also responsible for the negotiation and finalization of CSAs and for the maintenance of the TMF/ eTMF.

Regulatory and start-up activities in compliance with Directive 2001/20CE and Clinical Trial Regulation 536/2014

- To assist the Project Manager during the clinical trial activities (contacts with study Sponsor, CRAs coordination, eCRF management, work progress reports for invoicing);- To archive the clinical trial documents in the TMF/ eTMF; - To assist drug related activities, from accountability to resupply; - To perform regulatory and start-up activities (contacts with ECs, collecting site specific documents, setting up the package for submission); - To assist the study submission activities through OsSC.

Acquired skills:- Western Blotting- Real-Time PCR- Immunofluorescence - Cell Culture- Transfection- Scratch assay- Co-immunoprecipitation- Bacterial Transoformation