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Business Analyst Clinical Data

Morrisville, NC, US • Posted 4 hours ago • Updated 4 hours ago

Full Time

On-site

Depends on Experience

Promantis Inc

Fitment

Dice Job Match Score™

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Job Details

Skills

Business Analysis
regulated environments
Life Sciences
Pharma
Healthcare
Clinical Data Management
Biostatistics
FDA 21 CFR Part 11
GxP
HIPAA
IQ/OQ/PQ documentation
CDISC
CDISC (SDTM/ADaM)
FDA eCTD
Microsoft Fabric
Power BI

Summary

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91007012
Position Id: 8957967
Posted 4 hours ago

Company Info

About Promantis Inc

Since 2007, Promantis has been offering competitive services in consulting, technology and outsourcing. With scalability and flexibility to support long-term growth, we leverage this people advantage coupled with technology to develop industry-specific solutions in the domains of Health, Insurance, Telecommunications, Service, Pharmacy, Retail, Banking and Government.

Promantis offers services ranging from Contract Consulting, Staff Augmentation Services, Enterprise Application Solutions, Software Application Solutions, Systems and Network Engineering to Service and Support. Promantis has an expert staff of consultants waiting to assist you. This includes Project Managers, Business System Analysts, Functional Consultants, and Technical Consultants with skills ranging from legacy systems to the latest technologies.

As a recognized leader providing customized software services and solutions to companies around the world, our ability to deliver is a granted that makes companies put their trust in us to answer their day-to-day business challenges and put them on a path for greater success.

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