Clinical Data Standards Manager

BioSpace; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Manager, Clinical Data and Reporting Standards (CDARS) who will help develop data and reporting standards for clinical trials and ensure CDISC conformance across SDTM/ADaM. You will implement governance frameworks and drive next-generation processes and technology.

The role involves cross-functional collaboration, creating documentation, training materials, and communicating standard development activities to the organization, with opportunities to influence

Qualifications

• SDTM programming experience required.
• Experience developing data collection, tabulation, analysis or reporting standards.
• Experience preparing SDTM/ADaM datasets and regulatory submission documentation.

Responsibilities

• Develop and define data standards (data collection, review rules, SDTM mapping).
• Define ADaM mapping, study tables, listings or figures, and safety analysis displays.
• Ensure standards are well documented with assumptions and decisions.
• Create training materials and communicate ongoing standard development activities to the organization.
• Ensure consistency across SDTM/ADaM/CDASH standards and related processes.

Skills

SDTM programming

Standards development

Regulatory submissions

Education

MS in relevant field

BS in relevant field

Job description

AbbVie in Irvine, CA is seeking a Manager, Clinical Data and Reporting Standards (CDARS) who will help develop data and reporting standards for clinical trials and ensure CDISC conformance across SDTM/ADaM. You will implement governance frameworks and drive next-generation processes and technology.

The role involves cross-functional collaboration, creating documentation, training materials, and communicating standard development activities to the organization, with opportunities to influence