Perform end‑to‑end business and systems analysis for HRS‑based RWE studies, translating life sciences protocols into clear, testable system requirements
Support study initiation and delivery by contributing to scope definition, feasibility discussions, configuration decisions, and risk identification under guidance from senior leadership
Apply domain knowledge of Real World Evidence study designs, participant data collection, and scientific data workflows to inform system design and delivery decisions
Support configuration activities of data managers, including ensuring alignment to product capabilities
Integrate configuration documents with requirements documentation
Assess, analyze, and document requirements for custom development using appropriate techniques for highly configurable projects (e.g., protocol review, workshop output analysis, document analysis, review with product team, client approvals)
Produce high‑quality requirements artifacts leveraging reusable and single sourced content, including business requirements, user stories, acceptance criteria, process flows, and data flows
Support the data managers to convey configuration and integration needs to the technical teams, aligned with HRS platform capabilities and product standards
Support engineering teams throughout build and test phases by clarifying configuration and requirements, validating solutions, and minimizing rework
Apply good data management practices to ensure data integrity, privacy, and compliance with HIPAA, GDPR, and other applicable research regulations
Identify risks, issues, and dependencies within assigned studies and escalate appropriately with recommended mitigations
Support audits, inspections, and internal reviews by maintaining accurate, complete, and compliant documentation
Work closely with Project Managers to support delivery planning, milestone tracking, and change management activities
Collaborate with Product, Engineering, Epidemiology, and Data Management partners to ensure requirements align with scientific objectives and platform capabilities
Communicate clearly with internal stakeholders and external clients to explain system functionality, requirements decisions, and delivery impacts
Support user acceptance testing and deployment activities
Provide informal mentoring and peer review support to Business Analysts, promoting consistent analysis quality and adherence to standards
Contribute to reusable templates, documentation standards, and best practices for HRS life sciences delivery
Continuously build domain and technical expertise in real world evidence, healthcare data standards, and regulated system delivery.
Requirements
Bachelor’s degree in Computer Science, Health Sciences, Biotechnology, Business Administration, or a related field (or equivalent experience)
Typically 6+ years of experience in business or systems analysis, including hands‑on experience delivering healthcare or life sciences data systems
Working knowledge of Real World Evidence study designs
Practical experience applying healthcare data standards and models (e.g., HL7 FHIR, OMOP)
Understanding of data management considerations for scientific datasets, including longitudinal and participant‑reported data
Strong analytical and problem‑solving skills, with the ability to independently resolve moderately complex system and delivery issues
Proficiency with business analysis and collaboration tools (e.g., Jira, Confluence, Excel, PowerPoint, diagramming tools)
Ability to produce clear, accurate, and audit‑ready documentation
Strong written and verbal communication skills, with the ability to engage effectively with cross‑functional teams.
Experience supporting observational, registry, clinical research, or other human subjects research studies
Experience working with decentralized, direct‑to‑participant, or digital health research platforms, including Health Research Space
Familiarity with healthcare coding systems (e.g., SNOMED, ICD, LOINC)
Exposure to SQL, JSON, or scripting languages (e.g., Python, R, SAS)
Experience working with global or cross‑regional delivery teams