Data Manager ll

POSITION SUMMARY

DUTIES

• Support development and maintenance of the Master Data Management and Data Quality Plan, including governance processes, quality objectives, data stewardship responsibilities, business validation rules, reporting requirements, and continuous-improvement activities.
• Define, monitor, analyze, and report data-quality measures such as datasets received/processed, successful loads, validation failures, error types, business-rule exceptions, curation activity, processing timeliness, resolution time, and recurring quality trends.
• Develop and maintain data-quality reports and near-real-time dashboards that provide FDA visibility into workload, processing status, validation results, productivity, quality indicators, and historical performance.
• Lead documentation, inventory, impact assessment, and governance of business validation rules used in study-data acquisition, validation, loading, curation, and reporting; coordinate approved changes across OCS tools and services.
• Analyze recurring data-quality and operational issues, perform root-cause assessment, recommend corrective and preventive actions, and identify opportunities for automation, workflow improvement, metadata management, and stronger governance controls.
• Coordinate with OCS Data Central modernization resources so data-quality measures, validation rules, dashboards, metadata, and governance requirements are incorporated into future enhancements.
• Participate in Data Governance Board and stakeholder meetings; communicate quality findings, risks, trends, and recommendations in a form suitable for both technical and program leadership audiences.

EDUCATION

REQUIRED QUALIFICATIONS

• Demonstrated experience in data quality management, data governance, stewardship, metadata, validation, data lifecycle controls, and operational reporting in regulated or enterprise environments.
• Experience defining quality metrics, analyzing trends and exceptions, maintaining business/data rules, and translating findings into practical process or system improvements.
• Working knowledge of structured data processing, validation, curation, reporting, and data-management controls; ability to collaborate with technical, scientific, and business stakeholders.
• Strong analytical, documentation, communication, and problem-solving skills.
• Must be able to obtain and maintain a High-Risk Public Trust or equivalent federal client access. This role supports sensitive federal programs and involves elevated access to systems and data.
• Position requires the current ability to obtain and maintain required access without interruption in alignment with long-term program needs.
• Must be authorized to work in the United States without employer sponsorship now or in the future.

PREFERRED QUALIFICATIONS

• Experience with FDA/CDER study-data operations, clinical/nonclinical regulatory data, CDISC SDTM/ADaM/SEND concepts, FDA business or validation rules, DataFit or comparable validation tools, SQL/reporting platforms, dashboarding, data governance forums, and enterprise data modernization.

ABOUT APV