Katrin Najjar

Compliance und Qualitätsmanagement der Studiendurchführung nach GCP Risikomanagement, Trendanalyse, Reporting

- conducting feasibilities for new studies - submission of clinical vaccine trials to the Ethics Committees - conducting clincial trials

• Monitoring of several sites in vaccines, oncoligical and antibiotic studies • Performing Site Qualification and Site Initiation Visits • Study site set-up incl. collecting pre-study information, documents, RDC access information from sites

• Site Monitoring • Collection and consolidation of tracking information • Organizing of serum sample collections from sites and shipments to US • Vaccine shipment organization together with other internal departments • Clearing of data requests/ DCFs

• • Training and first performance of autonomous site monitoring • Obtaining relevant study documents for Ethics Committee submission • Organizing of serum sample collections from sites and shipments to US • Vaccine shipment organization together with other internal departments • Clearing of data requests/ DCFs

• Inhouse monitoring including: providing of translations, resolving of data inconsistencies etc. • Creating of CRFs, Diaries • Collecting of tracking information • Clearing of data requests

• Inhouse monitoring including: providing of translations, resolving of data inconsistencies etc. • Creating/designing of CRFs, Diaries • Collecting of tracking information • Clearing of data requests

• Project Leader of female health studies CDM • Cleaning of study data bases including creating of data requests, data modifications, creating data listings