Protocol Data Engineer

POSITION TITLE:Protocol Data Engineer LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity.

Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions.

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Our teams create intelligent chatbots, AI-powered assistants, robotic process automation (RPA), essay graders, and data analytics platforms.

Ifyourepassionate about solving complex challenges and shaping the future, APV is the place for you.

Since 2007,wevepartnered 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 andwerelooking for exceptional talent to grow with us.

At APV, we Always Provide Value POSITION SUMMARY Provides hands-on data engineering and database implementation expertise to operationalize structured protocol data models and support the FDA proof of concept for AI-assisted clinical trial protocol review.

The role translates approved clinical, standards, and technical models into scalable data structures, transformations, retrieval workflows, and traceable outputs within FDA-approved environments.

DUTIES Implement protocol data structures and physical schemas that support extraction, normalization, storage, retrieval, comparison, and reviewer-facing use of both ICH M11-aligned and historical protocols.Translate approved ICH M11, CDISC USDM, ontology, metadata, and terminology models into practical database structures and data-engineering components for the POC.Develop and support ETL/ELT pipelines and data transformations for protocol content and structured outputs, preserving source provenance, metadata, assumptions, validation status, and reviewer feedback.Support retrieval-augmented generation (RAG), semantic retrieval, indexing, evidence caching, and protocol comparison components in collaboration with AI/prompt engineering and standards SMEs.Support integration with FDA-furnished Elsa/HALO capabilities and FDA-approved data services, including PostgreSQL and/or HALO/Databricks, for protocol evidence caching, retrieval, analytics, and dashboard-ready outputs.Develop advanced SQL and data-access logic supporting protocol extraction, historical retrieval and comparison, reviewer dashboards, and traceability to source evidence.Execute data-focused quality assurance, reconciliation, validation, and regression testing, including checks for completeness, mapping consistency, retrieval quality, unsupported values, ambiguity, and reproducibility.Document data models, interfaces, transformations, mappings, implementation...