Senior Clinical Trial Scientist (m/w/d)

Beschreibung

• Core member of the clinical trial team (CTT)
• Collaborate closely with the Clinical Trial Physician (CTP) on relevant trial-related activities
• Develop a sound understanding of the science and medicine related to an indication and trial and perform literature searches as needed to keep knowledge up to date
• Main deliverables include the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR
• Provide input into and review cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual
• Perform data review and medical monitoring during the conduct of the trial
• Coordinate/manage the study committees
• Provide scientific input into responses for IRBs/ECs and Has
• Participate in discussions with external experts
• Train the relevant functions and roles on the scientific aspects of the trial
• Contribute to cross-functional and clinical development initiatives and processes as needed

• PhD, Pharm D, MSc or equivalent university degree in life or health sciences
• At least 5 years of working experience in clinical development, in a contract research organization (CRO) or pharmaceutical company
• Experience in writing clinical study protocols, ICFs, scientific trial-related documents e.g., study committee charters
• Experience/Knowledge in the filed of kidney diseases and/or autoimmune diseases is desirable
• Solid experience in planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective
• Previous scientific contribution to cross-functional trial documents (e.g., SAP) guidelines, CRFs
• Solid experience with data review/medical monitoring
• Previous contributions to scientific discussions with external experts
• Good understanding of cross-functional clinical trial team roles, responsibilities, processes, and deliverables
• Good understanding of the drug development process, trial-related regulatory requirements/ICH GCP guidelines
• Fluent in English (written and oral)