Clinical Trial Scientist

Reference Number: 895648-W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Our client is a leading biopharmaceutical company which continuously invests in innovation and growth. They are looking for a Clinical Trial Scientist.

Main Responsibilities:

  • Contribute to all key phases of trial (set up, run, closure)
  • Develop a sound understanding of the science and medicine related  to a trial, including competitive landscape
  • Accountability for the Clinical Science trial-related Protocol, incl. amendments and the Clinical Study Report and deviations
  • Accountability for the following trial-related activities: Scientific training of the Clinical Trial Team members, management of  Steering Committee, Independent data monitoring committee management, Event Committee management, PD management, Review of non-medical coding, Filing of CS trial documentation
  • Responsibility for delivering Subjects' narratives and Core Informed Consent Form
  • Responsible for the review of the following documents generated by other departments: Data Review Manual, Statistical Analysis Plan, Dummy tables, Case Report Form, External Service Providers, user requirements and data transfer specifications, Review of medical coding

Qualifications and Experience:

  • PhD, Pharm D, DVM, MSc or equivalent degree in Biological Sciences
  • 2-3 years' experience in clinical research in a clinical research organization or Pharmaceutical Company
  • The following clinical trial-related experience is required:
    • Previous co-authoring of: ICF, protocol, narrative
    • Previous involvement and able to define: protocol deviations, CRF specifications, medical monitoring, CS input to trial-related guidelines/instructions and SAP
    • Previous involvement in study design discussion (e.g., outline elaboration, amendment, CDP, discussion with external experts)
  • Good knowledge of drug development and clinical trial process based on previous deliverables
  • Good knowledge of regulatory requirements/ICH guidelines
  • Excellent organizational and problem solving skills, interpersonal skills and the ability to work under pressure and meet short timelines
  • Fluent in written and spoken English

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