Functional Business Analyst

POSITION TITLE: Functional Business Analyst

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 Functional (Business) Analyst - Expert / Knowledge Management Lead will lead process documentation, knowledge management, requirements analysis, and organizational knowledge-transfer activities for FDA/CDER OCS Data Management and Data Quality (DMDQ) operations. The role will work across operational, data-quality, and modernization workstreams to ensure business processes, SOPs, requirements, technical artifacts, lessons learned, and training materials remain current, usable, version controlled, and accessible to Government and contractor personnel.

DUTIES

• Lead and maintain the centralized DMDQ Knowledge Management Repository in FDA-designated collaboration platforms, organizing SOPs, project and technical documentation, process maps, user guides, business and validation rules, lessons learned, training materials, and knowledge-transfer artifacts.
• Elicit, analyze, document, and validate business and operational requirements with OCS stakeholders, tool teams, service teams, data managers, and technical personnel; translate requirements into clear process, workflow, reporting, and modernization needs.
• Document and continuously improve business processes supporting study data acquisition, validation, loading, curation, data quality, governance, reporting, workflow automation, system integration, incident/change management, and operational support.
• Develop, review, and maintain SOPs and operating guides; ensure documentation is technically accurate, logically organized, version controlled, and updated as procedures, policies, business rules, or systems change.
• Plan and facilitate knowledge-transfer, cross-training, system walkthroughs, process demonstrations, lessons-learned sessions, and Government training to reduce key-person dependency and preserve continuity of operations.
• Support Task 3.2 data-quality reporting and Task 3.4 modernization through requirements analysis, user stories/use cases, acceptance criteria, UAT coordination, process impact analysis, and traceability between business needs and implemented capabilities.
• Track documentation status, knowledge gaps, training needs, and process-improvement opportunities; provide metrics and recommendations to the Project Manager and FDA stakeholders.

EDUCATION

Experience level, education, and qualifications consistent with the applicable RRS BPA Functional (Business) Analyst Expert labor category.

REQUIRED QUALIFICATIONS

• Demonstrated experience leading business analysis, requirements elicitation, process mapping, SOP/document development, knowledge management, and stakeholder facilitation in complex technical or regulated environments.
• Ability to translate operational and technical information into clear, actionable documentation for business, scientific, and technical audiences.
• Experience with document repositories, version control, workflow/process documentation, requirements traceability, and quality review of deliverables.
• Strong written communication, facilitation, organization, and cross-functional coordination 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

• Prior FDA/CDER, pharmaceutical, biotechnology, clinical-data, or Federal health experience; familiarity with study-data workflows, data quality/governance, CDISC concepts, SharePoint, Jira or similar work-management tools, Agile delivery, EPLC documentation, and modernization or transition activities.

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.