1604 IT & Software Developer jobs in the US
Business Analyst/Project Manager - Clinical Data
$104,000 - 144,000
Tanisha Systems
North Whisman Road, Santa Clara
$104,000 - 144,000
Requirements
Must:
- Over 10 years of experience in IT, with at least 6 years in Business Analysis within regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics)
- Proven expertise in requirements gathering, documentation, and validation, as well as conducting workshops and creating functional specifications
- Deep understanding of FDA compliance standards (21 CFR Part 11, GxP, HIPAA)
- Familiarity with regulatory frameworks including GDPR and experienced in IQ/OQ/PQ documentation, SOPs, and producing audit-ready deliverables
- Strong knowledge of Clinical Data Management, Biostatistics workflows, CDISC (SDTM/ADaM), and FDA eCTD requirements
- Proficiency in tools such as GitHub Projects, DevOps board, Jira, and Power BI
- Understanding of Microsoft Fabric, governance policies, and compliance documentation, with exposure to BI solutions using Power BI
- Experience with CDISC/SDTM/ADaM standards, OMOP mapping, and advanced analytics (R, Python, SAS)
- Skilled in using AI-driven tools (e.g., GitHub Copilot, Microsoft Fabric Copilot, M365 Copilot)
- Bachelors degree in Life Sciences, Computer Science, or a related discipline
Responsibilities
- Lead requirement analysis sessions and translate regulatory/business needs into functional specifications
- Document user stories, acceptance criteria, and workflows while creating Business Requirement Documents (BRD) and Functional Requirement Specifications (FRS)
- Define validation rules to ensure dataset version control, audit trails, and electronic signatures while partnering with QA teams for validation documentation and SOPs
- Capture reporting requirements for Power BI dashboards, compliance scorecards, and monitoring reports; ensure they align with governance and audit workflows
- Facilitate stakeholder engagement through workshops, User Acceptance Testing (UAT) sessions, and requirement reviews, serving as the bridge between business stakeholders and technical teams
- Monitor data quality dashboards, resolve issues, and define secure vendor data exchange protocols
- Contribute to the roadmap for CDISC/SDTM/ADaM integration, OMOP mapping, advanced analytics, and AI insights
- Build productive relationships to enhance collaboration, providing constructive feedback to address requirement gaps and compliance challenges
- Work within an Agile/Scrum framework using Jira or Azure DevOps
Description
We are seeking a seasoned Business Analyst/Project Manager for our Clinical Data team based in Morrisville, NC. This full-time role offers a competitive salary based on experience and is designed for candidates located locally. Our ideal candidate will drive the collection of requirements and ensure compliance for our cloud-native data platform developed on Microsoft Fabric and Azure. We value innovation and collaboration, and our goal is to enhance analytics capabilities while maintaining rigorous regulatory standards. The successful candidate will play a crucial role in aligning clinical stakeholders with technical teams, thereby contributing significantly to our data-driven initiatives.
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How many Business Specialist jobs are in the United States?
Currently, there are 1604 Business openings. Check also: Project-Manager jobs, Product-Manager jobs, CRM jobs - all with salary brackets.
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Which companies are hiring for Business Specialist jobs in the United States?
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The company with most openings is Jobot as they are hiring for 139 different Business Specialist jobs in the United States. They are probably quite committed to find good Business Specialists.
The company with most openings is Jobot as they are hiring for 139 different Business Specialist jobs in the United States. They are probably quite committed to find good Business Specialists.