Clinical Scientist

Reference Number: 895401-W
Type of placement: Permanent, Permanent
Location: Switzerland, North West

Introduction:

·

  • The Clinical Scientist is a core member of the Clinical Trial Team
  • The tasks and activities of the Clinical Scientist are carried out in close collaboration with the Senior Clinical Scientist, Clinical Trial Physician for the trial-related activities and with the Project Leader for the project-related activities

Main Responsibilities:


Tasks and activities at the trial level:
  • Develops a sound understanding of the science and medicine related to a trial
  • Responsible, with the Senior Clinical Scientist, for delivering the following Clinical Science trial-related documents:
    • Protocol
    • Core Informed Consent Form (CICF)
    • Clinical Study Report (CSR)
    • Subjects' narratives
  • Responsible for the review of the following documents generated by other departments:
    • Case Report Form (design, completion)
    • Data Review Manual
    • Statistical Analysis Plan
    • Safety Management Plan
    • External Service Providers' user requirements and data transfer specifications
    • Pharmacy Manual, IxRS Manual
    • Independent data monitoring charter
    • Laboratory Manual
    • Review of medical coding
  • Responsible, with the Senior Clinical Scientist, for the following trial-related activities:
    • Scientific training of the Clinical Trial Team members
    • Steering Committee management with Clinical Operations
    • Independent data monitoring committee management with Clinical Operations
    • Clinical Evaluation Committee management (including charter)
    • Clinical data cleaning and data review
    • Protocol deviations management
    • Review of Safety Report, including interaction with the external Drug Safety Provider Filing of Clinical Science trial documentation with the Clinical Trial Assistant
    • Answer to trial-related health authorities questions
    • Answer to EC/IRB questions
    • Safety monitoring
    • Medical training of the Clinical Trial Team members
    • Trial-related communication, internally and externally (e.g., motivation visit to sites)
    • Perform literature reviews

Qualifications and Experience:

  • An advanced degree (i.e., PhD, DVM, PharmD) in a relevant scientific discipline
  • At least 3-5 years experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company
  • Experience in all key phases of a trial (set up, run, closure)
  • Previous co-authoring of essential documents, e.g., protocol, Core Informed Consent Form
  • Previous involvement and able to define: protocol deviations (PD), Case Record Form (CRF) specifications, medical monitoring, Clinical Science input to trial-related guidelines/instructions and Statistical Analysis Plan (SAP)
  • Previous involvement in study design discussion
  • Clinical research experience in the indication relevant to the Clinical Project is preferred
  • Good knowledge of drug development and clinical trial process based on previous deliverables
  • Good knowledge of regulatory requirements/ICH guidelines
  • Fluent in English (written and spoken)
  • Able to work both as part of a team and independently
  • Data driven
  • Open communication with all stakeholders
  • Flexibility, adapting to changing environment
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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