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Clinical Data Standards Specialist

Salary undisclosed

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Title: Clinical Data Standards Specialist

Duration: Full-Time, Permanent

Client: FDA

Location: Remote

Key Responsibilities

  • Participate in the creation and management of therapeutic and project level standards aligned with CDISC SDTM, SEND, and HL7 standards.
  • Act as an expert on SDTM standards and submission requirements.
  • Facilitate effective communication and collaboration between data standards group and reviewer teams, including statisticians, statistical programmers, and medical reviewers. Author and review SOPs and procedures for use of clinical data standards in the regulatory review process..

Qualifications

  • BA/BS in a relevant health science or computer science discipline and a minimum five (5) years experience as a clinical programmer or data manager in a pharmaceutical or CRO setting, or comparable relevant experience