Clinical Trial Scientist

Reference Number: 895648-W
Type of placement: Permanent

Introduction:

Our client is a leading biopharmaceutical company which continuously invests in innovation and growth

Main Responsibilities:

  • Collaborates closely with the Clinical Project Physician and Clinical Project Scientist 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:

  • PhD, Pharm D, MSc or equivalent university degree in life or health sciences
  • At least 2 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company
  • Previous experience in either the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective is an asset
  • 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
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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