Emmes · 3 hours ago
Clinical Systems Business Analyst - Essex Management
United States
Full-time
Remote
Senior Level
5+ years expEmmes is a biomedical informatics and health information technology-focused consultancy dedicated to transforming the future of clinical research. The Clinical Systems Business Analyst is responsible for leading requirements elicitation and process documentation to support the design and optimization of biomedical and clinical informatics software and systems, collaborating closely with various stakeholders to ensure alignment with research objectives and regulatory standards.
BiopharmaBiotechnologyClinical TrialsHealth CareMedical
Responsibilities
Serve as a primary liaison and trusted advisor to clinical research stakeholders and communities to analyze current-state workflows, operational challenges, and process constraints
Lead and facilitate large-scale workshops and focused working sessions with clinicians, researchers, technical experts, and stakeholders to drive consensus and solution-oriented outcomes aligned to strategic business needs
Independently gather, elicit, analyze, and document functional and non-functional requirements, ensuring all stakeholder perspectives are captured and cross-project communications remain aligned
Collaborate with multidisciplinary clinical, technical, and data teams to design phased, incremental technology solutions, translating workflow and process requirements into clear functional specifications and acceptance criteria
Support solution development through iterative design, validation, and testing cycles, with emphasis on automation, efficiency gains, and responsible AI practices, while adhering to data governance, privacy, and security policies
Develop and maintain detailed process documentation using standard methodologies including workflow diagrams, storyboards, FMEA, process mapping, root cause analysis, value stream mapping, and stakeholder analysis
Identify pain points, bottlenecks, inefficiencies, and risk areas through direct workflow observation, data analysis, and collaborative discussions with end users
Support user acceptance testing (UAT) and solution validation by assessing functionality, usability, and workflow impact, providing design feedback informed by clinical domain expertise, UX principles, and human factors engineering
Support data conversion, data mapping, and system integration activities related to clinical systems implementations and interoperability initiatives
Serve as a Subject Matter Expert (SME) through deep knowledge of health information systems, clinical research operations, regulatory requirements, and data governance frameworks supporting complex biomedical informatics initiatives
Design, develop, and deliver comprehensive training materials and conduct educational sessions to support end-user adoption, accommodating diverse learning styles and experience levels
Provide post-implementation support and troubleshooting, ensuring sustained adoption, usability, and compliance with new tools and workflows
Communicate effectively across all organizational levels, presenting findings, risks, and recommendations to frontline users, technical teams, and leadership
Exercise strong independent judgment, balancing autonomous execution with appropriate escalation of risks, dependencies, or unresolved issues
Actively contribute to strategic initiatives while supporting operational execution, ensuring timely and high-quality delivery of clinical informatics solutions
Qualification
Required
Advanced process documentation standards and methodologies
Use case and functional requirements documentation
Business and process modeling
Storyboarding and workflow visualization techniques
Unified Modeling Language (UML), Rational Unified Process (RUP), BPMN
Microsoft Visio (advanced proficiency)
Information Technology and data analysis expertise
Stakeholder engagement and client relationship management
Experience in Clinical Trials, Clinical Data Management, Health Information Exchange (HIE), interoperability initiatives, Life Sciences research (biomedical, genomics), or regulated pharmaceutical environments
Cancer research domain knowledge
Exceptional written and verbal communication skills
Knowledge of medical and scientific imaging (radiology, microscopy, pathology)
Knowledge of semantics, ontologies, and data standards supporting cancer research
Familiarity with data analysis and data visualization tools
Knowledge of program management and business analysis frameworks
Master's degree in health informatics, clinical research administration, public health, or related field OR Bachelor's degree with 5-7 years of directly relevant experience
3-5+ years of experience in a regulated IT environment (Pharma, GxP, federal or healthcare regulations) supporting clinical informatics or clinical research operations
Experience working in IT and data-driven environments, supporting system interoperability, implementations, change management, and business process redesign
Demonstrated expertise in process mapping, workflow analysis, and structured risk assessment methodologies (e.g., FMEA)
Proficiency with business analysis and process modeling tools including Microsoft Visio, BPMN, UML, Jira, Confluence, and Azure DevOps, with demonstrated experience documenting requirements, workflows, and use cases in regulated clinical or research environments
Hands-on experience with health IT systems, data standards, and interoperability frameworks, such as EHR/EDC/CTMS platforms, HL7/FHIR, CDISC, SNOMED, LOINC, OMOP, and related data analysis and visualization tools (e.g., SQL, Excel, Power BI, Tableau)
Experience supporting system testing, validation, and compliance activities, including UAT, GxP or CSV documentation, and change management, with preferred certifications in Business Analysis (CBAP, PMI-PBA), Healthcare Informatics (CPHIMS, AMIA 10x10), Project/Process (PMP, ITIL, Lean Six Sigma), or health data standards and governance
Proven ability to independently manage stakeholder engagement, translating between clinical, scientific, and technical audiences
High adaptability and rapid learning ability across new clinical, research, and technology domains
Established experience presenting complex information to leadership at all organizational levels, tailoring content to audience needs. Strong instructional and facilitation skills, with ability to train diverse user populations
Benefits
Flexible Approved Time Off
Tuition Reimbursement
401k Retirement Plan
Work From Home Anywhere in the US
Maternal/Paternal Leave
Casual Dress Code & Work Environment
Company
Emmes
Emmes is a contract research organization that offers clinical research services for public health and biopharmaceutical innovation.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Behrman Capital
2022-06-21Acquired
2019-03-04Private Equity
Leadership Team
Peter Ronco
Chief Executive Officer
Recent News
2025-09-20
2025-01-18
2024-12-10
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