Clinical Protocol Lead

POSITION TITLE: Clinical Protocol Lead

LOCATION: Remote

CLEARANCE: Must be able to obtain a High-Risk Public Trust

COMPANY OVERVIEW

At APV, we’re more than a technology company — we’re a mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Our expertise spans AI/ML, data architecture, low-code/no-code development, Agile DevSecOps, and cloud services, delivering scalable and meaningful solutions.

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.

At APV, we Always Provide Value

POSITION SUMMARY

The Clinical Protocol Lead provides functional leadership for initiatives that structure, standardize, analyze, and compare clinical trial protocol information. The role combines clinical research informatics, data standards, metadata and terminology expertise with practical experience in regulatory data analysis and AI-assisted review. This position serves as a bridge between clinical and regulatory subject matter experts, standards specialists, analysts, and technical teams to ensure protocol information is accurate, traceable, interoperable, and fit for downstream review and analytics.

DUTIES

• Lead definition of protocol-focused use cases, reviewer questions, priority data elements, and comparison scenarios in collaboration with clinical, regulatory, standards, and technical stakeholders.
• Apply ICH M11, CDISC USDM, SDTM, ADaM, CDASH, controlled terminology, and related metadata standards to support consistent representation and interpretation of clinical trial information.
• Guide extraction, normalization, and semantic mapping of information from structured and unstructured protocols, including objectives, endpoints, eligibility criteria, study design, interventions, assessments, and other reviewer-relevant content.
• Develop and review data dictionaries, metadata specifications, terminology mappings, business rules, and traceability relationships across protocol content, study definitions, and downstream clinical data structures.
• Support AI-assisted and analytics-enabled protocol review by defining test cases, expected results, quality metrics, and human-review checkpoints; assess ambiguous, low-confidence, or inconsistent outputs.
• Partner with data architects, programmers, analysts, and software teams to translate clinical and regulatory requirements into implementable data models, transformation rules, and reviewer-facing workflows.
• Lead or support data harmonization and standards implementation across studies, therapeutic areas, or organizations, including stakeholder consensus-building, training, documentation, and process improvement.
• Contribute to project planning, requirements gathering, validation, lessons learned, and recommendations for improving protocol quality, machine readability, interoperability, and reuse.

EDUCATION

• Bachelor’s degree in biomedical informatics, life sciences, statistics, data science, public health, or a related discipline; master’s degree preferred.

REQUIRED QUALIFICATIONS

• 8+ years of experience in clinical research informatics, clinical data standards, regulatory data analysis, statistical programming, or related pharmaceutical/health research work.
• Hands-on knowledge of CDISC standards and structured clinical research information, with practical experience in metadata, data mapping, data harmonization, or standards implementation.
• Experience working with clinical trial protocols, statistical analysis plans, case report forms, submission datasets, or other regulated clinical research content.
• Strong ability to work across clinical, scientific, regulatory, and technical teams and to translate complex requirements into structured, testable specifications.

PREFERRED QUALIFICATIONS

• ICH M11 and/or CDISC USDM experience, including protocol-to-study-definition mapping, study design metadata, or structured protocol implementation.
• Experience with controlled terminology, semantic interoperability, NCI EVS or similar terminology services, common data elements, or metadata repositories.
• Experience with SAS, R, Python, SQL/PostgreSQL, or comparable analytical/data platforms; familiarity with cloud or modern data environments is beneficial.
• Exposure to generative AI, automated document classification/extraction, AI-assisted regulatory review, or analytics automation in clinical or regulatory settings.
• Experience leading cross-functional or global teams, standards committees, training efforts, or stakeholder working groups.

ABOUT APV

APV is an Equal Employment Opportunity employer. All qualified applicants are considered without regard to race, color, religion, sex, national origin, age, disability, genetic information, sexual orientation, gender identity, veteran status, or marital status.