Viktoria Tierbach

Project and Quality Management, Sponsor Oversight, timelines and budget of Clinical Trials Phases I-III Ethic Committee and Regulatory Authority Submissions Co-monitoring assess CRAs and site performance Design and local adaptations of study documents Contract Management and Selection of investigational sites and external vendors Managing CTMS and eTMF Data validation, including data listings review Collaboration with international clinical trial teams

 Study Coordinator for Single-Center Trials  Monitoring Clinical Trials Phases I-III  Managing Trial, Site and Investigator  Ethic Committee Submission  Site vaccine and ancillary supplies  Human specimens  Managing eTMF  Review CRO monitoring visit reports  Co-monitoring of CRO-CRAs

Management and analysis of clinical trials, data management, documentation, database programming, biostatistics