Clinical Systems Business Analyst (Jr & Mid) – Multiple Openings - Essex Management (Contingent Role)

Emmes Group•Rockville, MD

6d•Remote

About The Position

This position supports Essex, an Emmes Company, a biomedical informatics and health IT consultancy founded in 2009 and headquartered in Rockville, MD. Essex specializes in developing and managing complex health and biomedical information programs for federal agencies, academic research institutions, and private-sector clients. Emmes Group is transforming the future of clinical research, advancing innovation in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. We are committed to improving patient outcomes through data, technology, and scientific excellence. We are currently hiring for multiple Clinical Systems Business Analyst roles across two levels (Level I and Level II), with multiple positions available at each level. The Clinical Systems Business Analyst serves as the critical bridge between clinical/research operations and technical delivery teams. The role translates business needs, clinical workflows, and stakeholder requirements into actionable functional specifications, process improvements, and system solutions. Both levels support: Requirements elicitation and documentation, Process analysis and optimization, Clinical systems implementation and integration, Data-driven decision-making and workflow improvement, User adoption, training, and change management. Level II represents a more senior, independent, and advisory role with deeper domain expertise and leadership expectations.

Requirements

Bachelor’s degree in Health Informatics, Clinical Research, Public Health, IT, or related field required
Jr: 1–3 years in clinical IT, informatics, or regulated research environment
Mid: 3–6 years progressive experience with demonstrated independent contribution
Experience may include: Clinical research or pharmaceutical environments (GxP, GCP), Federal health IT systems (NIH, HHS, VA, DoD, NCI, etc.), Clinical informatics or EHR/EDC/CTMS implementations, System integration, interoperability, or business process redesign
Process & Analysis: BPMN, UML, workflow mapping, value stream mapping, FMEA, root cause analysis, Microsoft Visio and similar tools
Clinical Systems & Standards: EHR, EDC, CTMS platforms, HL7, FHIR, CDISC, SNOMED, LOINC, OMOP
Tools & Technology: Jira, Confluence, Azure DevOps, SQL, Excel, Power BI, Tableau, Configuration management and version control tools
Testing & Compliance: UAT support, GxP / 21 CFR Part 11 / CSV validation experience, Regulatory and audit readiness support
Core Competencies: Strong analytical and structured thinking, Excellent communication across technical and clinical audiences, Workshop facilitation and stakeholder alignment skills, Ability to work independently (increasing with level), Adaptability across clinical, regulatory, and technical domains, Strong organizational skills and attention to detail

Nice To Haves

Master’s degree preferred (may substitute for experience)
Exposure to biomedical domains (e.g., oncology, imaging, pathology) is a plus
Certifications such as: PMI-PBA, CBAP, PMP, ITIL 4 Foundation, Lean Six Sigma (Green Belt for Level I, Black Belt for Level II), CPHIMS, AMIA 10x10, GCP/ICH E6 training
Experience supporting federal agencies (NIH, NCI, VA, DoD, HHS)
Familiarity with government contracting environments and compliance frameworks

Responsibilities

Lead and facilitate workshops with clinicians, researchers, technical teams, and leadership
Elicit, analyze, and document functional and non-functional requirements
Translate business needs into clear user stories, use cases, and acceptance criteria
Communicate findings and recommendations across all organizational levels
Develop workflow diagrams, process maps, FMEA, value stream maps, and root cause analyses
Identify inefficiencies, bottlenecks, and operational risks
Maintain structured documentation repositories and knowledge assets
Collaborate on clinical and technical solution design and delivery
Support system integration, data mapping, and interoperability initiatives
Contribute to automation, efficiency improvements, and responsible AI adoption
Ensure adherence to data governance, privacy, and compliance requirements
Support UAT, system validation, and usability testing
Provide clinical and workflow feedback during system development cycles
Support post-implementation troubleshooting and adoption
Contribute to change management and training activities
Develop training materials and deliver end-user training sessions
Serve as SME in clinical systems, workflows, and informatics domains
Support adoption of new systems and workflows across user groups