Business Analyst/PM - Clinical Data

Business Analyst/PM - Clinical Data Morrisville, NC 27560 - Onsite Role - Prefer local candidates Salary Market (DOE) FTE role We are looking for a seasoned Business Analyst with experience in requirement analysis and delivery of data & analytics solutions for regulated industries (Life Sciences / Pharma). The ideal candidate will drive requirement gathering, compliance alignment, and stakeholder engagement for a GxP-compliant, cloud-native data platform on Microsoft Fabric and Azure. Success will be measured by the ability to translate CDM/Biostatistics needs into validated pipelines, dashboards, and audit-ready documentation. The Business Analyst acts as the bridge between clinical stakeholders and technical teams, ensuring requirements are captured, translated, and delivered effectively. Leads requirement gathering & documentation across CDM, Biostatistics, and vendor partners. Translates business and regulatory needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA. Supports validation frameworks, audit-ready documentation, and reporting requirements such as Power BI dashboards and compliance scorecards. Facilitates workshops, UAT sessions, and milestone signoffs to secure stakeholder alignment. Prepares for future readiness, advanced analytics, and AI-driven insights. Skills / Experience 10 years in IT with 6 years in Business Analysis for regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with FDA 21 CFR Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA, GDPR; experienced in IQ/OQ/PQ documentation, SOPs, and audit-ready deliverables Strong domain knowledge in CDM, Biostatistics workflows, CDISC (SDTM/ADaM), FDA eCTD; Tools: GitHub Projects, DevOps board, Jira, Power BI, Microsoft Fabric Understanding of Microsoft Fabric, governance policies, compliance documentation; exposure to BI solutions using Power BI Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, advanced analytics (R, Python, SAS), and AI-driven accelerators (WinAIDM) Skilled in stakeholder engagement, workshops, UAT sessions, and cross-functional collaboration Experience defining validation rules, monitoring dashboards, and exception handling processes Experience leveraging GenAI tools (GitHub Copilot, Microsoft Fabric Copilot, M365 Copilot) Bachelor s degree in Life Sciences, Computer Science, or related field Role / Job Description Requirements Analysis & Translation Lead requirement gathering sessions; translate regulatory and business needs into functional specifications; document user stories, acceptance criteria, and workflows; author BRD and FRS Data Governance & Compliance Define validation rules; ensure dataset versioning, lineage, audit trails, and electronic signatures; collaborate with QA teams for validation documentation and SOPs; support compliance reviews and inspection readiness Analytics & Reporting Enablement Capture reporting requirements for Power BI dashboards, compliance scorecards, and study progress reports; define business rules for secure analytics environments; ensure reporting aligns with governance and audit workflows Stakeholder Engagement & Delivery Facilitate workshops, UAT sessions, and requirement walkthroughs; act as liaison between business stakeholders and technical teams; drive milestone sign-offs for requirement validation and compliance readiness Operational Oversight & Vendor Collaboration Define secure vendor data exchange requirements; monitor data quality dashboards; coordinate issue resolution; ensure scalability and performance benchmarks Future Readiness Contribute to roadmap planning for CDISC/SDTM/ADaM integration, OMOP mapping, advanced analytics, and AI-driven insights Communication & Troubleshooting Build productive relationships across teams; provide feedback during workshops; troubleshoot requirement gaps, compliance risks, and process inefficiencies; work in Agile/Scrum projects with Jira or Azure DevOps Secondary Skills / Good to Have Life Sciences domain knowledge, deeper knowledge of clinical data flows, CDISC standards, regulatory submission processes, vendor data exchange practices Advanced Analytics & AI Exposure Awareness of AI-driven accelerators (WinAIDM, Fabric Copilot); exposure to RWE and predictive modeling in clinical trials Certifications / Good to Have CBAP, PMI-PBA, IIBA; Microsoft certifications (DP-600, DP-203) Expected Outcomes Phase 1 Clinical Data Repository delivered within 16 18 weeks; requirements translated into compliant workflows and validated pipelines; audit-ready documentation completed. Power BI dashboards and compliance scorecards actively used by stakeholders; improved collaboration across CDM, Biostatistics, IT, and vendors; foundation established for Phase 2 (CDISC/OMOP integration, advanced analytics, AI-driven insights). This Role Matters Ensures regulatory confidence by embedding compliance into every requirement; Drives operational efficiency by reducing manual data transfers and enabling secure vendor collaboration Enables analytics readiness by defining requirements for dashboards, scorecards, and validated pipelines; Fosters stakeholder alignment through workshops, UAT sessions, and milestone signoffs Lays the foundation for innovation, preparing the organization for CDISC/OMOP integration, advanced analytics, and AI-driven insightsaa415a4b-8b21-40fc-a65c-70d2b25ca29a