What are the responsibilities and job description for the Clinical Data Standards Specialist position at Trigent Solutions Inc.?
Title: Clinical Data Standards Specialist
Duration: Full-Time, Permanent
Client: FDA
Location: Remote
Key Responsibilities
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..
- 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
