Sr Business Analyst - Clinical

Job Title: Business Analyst – Clinical Data & Analytics Location: Raleigh, NC

Work Type: Onsite

Visa Requirement: No OPT / CPT

Open to only LOCALS of NC

Domain Knowledge – Clinical Data Management (CDM), Biostatistics workflows, CDISC (SDTM/ADaM), FDA eCTD. Collaboration Tools  – Github Projects / DevOps board / Jira , Power BI, Fabric Data Platform

About the Role:

The Business Analyst acts as the bridge between clinical stakeholders and technical teams, ensuring requirements are captured, translated, and delivered effectively. The ideal candidate should lead requirement gathering and 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 sign-offs to secure stakeholder alignment. Prepares for future readiness, advanced analytics, and AI-driven insights. 

Key Responsibilities:

Requirements Analysis & Translation • Lead requirement gathering sessions with CDM, Biostatistics, and vendor stakeholders. • Translate regulatory and business needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA. • Document user stories, acceptance criteria, and workflows for ingestion, validation, and reporting. • Author Business Requirement Documents (BRD) and Functional Requirement Specifications (FRS).

Data Governance & Compliance • Define validation rules across Bronze, Silver, and Gold layers (schema, business rules, certification). • Ensure requirements incorporate dataset versioning, lineage, audit trails, and electronic signatures. • Collaborate with QA teams to support IQ/OQ/PQ validation documentation and SOP creation. • Support compliance reviews and FDA/EMA 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 (Python, R, SAS integration). • Partner with technical teams to ensure reporting aligns with governance and audit workflows.