Clinical Trial Scientist

Vor 6 Tagen

Basel, Basel-Stadt, Schweiz CTC Vollzeit
  • Collaborates closely with the Clinical Project Scientist or Clinical Trial Physician 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, trial committee charters, trial guidelines / instructions, PD code list, participant narratives, and the CSR
  • Provides input into and reviews cross-functional trial documents such as the SAP, external service provider 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, HAs, sites and monitors
  • 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 4 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company. Monitoring experience is an advantage
  • 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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