Senior Clinical Trial Scientist
Main Responsibilities :
- Collaborates closely with the Clinical Trial Physician (CTP) on relevant trial-related activities
- Develops a sound understanding of the science and medicine related to an indication and trial and performs 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.
- Provides input into and reviews cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual.
- Performs data review and medical monitoring during the conduct of the trial.
- Coordinates / manages the study committees.
- Provides scientific input into responses for IRBs / ECs and HAs.
- Participates in discussions with external experts.
- Trains the relevant functions and roles on the scientific aspects of the trial.
- Contributes to cross-functional and clinical development initiatives and processes as needed
Qualifications and Experience :
- Relevant Swiss working / residency permit and / or Swiss / EU-Citizenship required;
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences
- At least 5 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company.
Monitoring experience is an advantage
- Experience in working in cross-functional environment. Able to coordinate cross-functional activities
- Experience in the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific and operational perspective
- Previous authoring / co-authoring of clinical trial protocols, ICFs, scientific trial-related documents (e.g., trial committee charters) is an advantage
- Previous experience in the Therapeutic area of Cardiovascular , Renal and / or Central Nervous System Diseases is an advantage
- Good knowledge of drug development and clinical trial process
- Good knowledge of regulatory requirements / ICH guidelines
- Demonstrated ability to work independently in a fast-paced environment, to prioritize multiple competing tasks, to proactively address issues and demands
- Fluent in written and spoken English
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