Skills / Experience
Only for locals from NC. This a Business Analyst Clinical Data Management (CDM) only applicable for this position.
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)
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