Data Manager ll

The Data Manager II - Data Quality & Governance specialist will support FDA/CDER OCS in operating and continuously improving the DMDQ Program. The role will provide senior data-management expertise focused on enterprise data quality, governance, business validation rules, operational metrics, stewardship, and corrective-action recommendations across clinical and nonclinical study-data workflows and supported OCS systems., * 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.

BS degree in computer science, engineering, data science, or related field of study, * 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., * 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.

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In our Emerging Technology Lab, innovation drives progress. Our teams create intelligent chatbots, AI-powered assistants, robotic process automation (RPA), essay graders, and data analytics platforms. If you’re passionate about solving complex challenges and shaping the future, APV is the place for you. Since 2007, we’ve partnered with federal and state agencies to deliver IT, training, and consulting solutions that achieve mission-critical outcomes. Built on accountability, integrity, and quality, we go beyond expectations. With 70+ prime contracts and a proven record of client success, APV continues to grow - and we’re looking for exceptional talent to grow with us.