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APV
Posted 20 days agoVerified live 1d ago

Data Manager ll

Brief overview

Remote
UndergradOr in progress
4+ yrsMinimum
Clearance requiredU.S. government
Data Quality ManagementData GovernanceData StewardshipMetadata ManagementData Validation and Business RulesData Lifecycle ControlsOperational ReportingStructured Data Processing and CurationData Quality Metrics and Trend AnalysisSQLDataFitCDISC SDTM/ADaM/SENDFDA/CDER Regulatory Study DataHigh-Risk Public Trust Clearance

About the company

At APV, we are a mission-driven powerhouse that transforms organizations through advanced technology and innovative IT solutions.

Job description

Summary

APV is a mission-driven technology company delivering AI/ML, data architecture, cloud, and consulting solutions for federal and state agencies. The Data Manager II will support FDA/CDER OCS in operating and improving the Data Management and Data Quality Program, focusing on enterprise data quality, governance, validation rules, operational metrics, stewardship, and corrective actions. The role also develops dashboards, analyzes data-quality issues, coordinates modernization efforts, and communicates findings to technical and program leadership.

Responsibilities

  • 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

Skills

  • 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
  • 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

Qualifications

Must Haves

  • 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
  • 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

Nice to Haves

  • 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

Benefits

  • Remote work arrangement

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