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Roche

Sr. Clinical scientist

Primary Responsibilities and Accountabilities

  • Lead development and writing of protocol and related documents, e.g. case report form (CRF), informed consent form (ICF), source document verification plan (SDV)
  • Key-contributor to response to questions from regulatory agency/institutional review boards (IRB)
  • Co-lead with physician scientist the ongoing review of study data
  • Assist in the management of studies and support the training and science input to operation colleagues and study site staff
  • Serve as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies
  • Provide clinical scientific input for final study reports and annual report documentation
  • Support safety representatives in the serious adverse events reporting process
  • Represent translational medicine in study management teams and may represent translational medicine in clinical team meetings
  • Ensure GCP compliance in assigned pharma research and early development studies
  • Assist in the preparation of the clinical development plan
  • Give input to and reviews clinical regulatory documents (clinical study reports, investigator’s brochure, safety reports, submission to health authorities)
  • Assist in preparing materials for use in internal and external presentations (e.g. advisory board meetings)
  • Present results at team meetings and/or investigator meetings

Qualifications and experience

  • PhD-/MD-/PharmD-level (or equivalent relevant experience)
  • Five or more years of experience in clinical research
  • Ability to acquire knowledge in different diseases and therapeutic areas
  • Leadership skills, including motivating, delegating, coaching, and mentoring
  • Personnel managerial skills
  • Demonstrates and applies independent thought in projects
  • Effective scientific communicator
  • Recognized externally in own field
  • A team player with communication skills
  • Fluent in English
  • Ability to travel nationally, regionally, and/or internationally
  • Clinical research experience in hepatitis or infectious disease is a plus

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Development

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