Aufgaben•Operational support with start-up activities of study sites
• Plan and manage meetings with CROs and vendors
• Manage and oversee CRO and other vendors for selected deliverables
• Support Senior COM with the preparation of forecasts and status reports
• Effective collaboration with other internal functions such as Clinical Supplies, Pharmacovigilance, Clinical Quality Assurance, Legal, etc.
• Review and/or prepare trial related documents (manuals, plans, guidelines, visit reports, newsletters)
• Support set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, Centralized Monitoring Platform, RACT, etc.
• Function as a Risk Review Coordinator for CluePoints CMP
• Set-up, maintenance and quality check of eTMF
Qualifikationen• At least 2 years’ experience as a Lead CRA or Clinical Trial Manager of phase II – III at CRO and/or pharmaceutical industry preferentially in oncology
• CRA experience in oncology is a plus
• Solid understanding of operations on global multi-center trials
• Robust knowledge of ICH-GCP and clinical trial regulations
• Effective communication, organizational, problem solving and time management skills
• Excellent team working skills in international and cross-functional environment
• Fluent in English, knowledge of German is a plus