Clinical Systems Business Analyst (Jr & Mid) - Multiple Openings - Essex Managem

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. Primary Purpose (Both Levels)

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, Core Responsibilities (Both Levels)1. Stakeholder Engagement & Requirements
• 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

2. Process Analysis & Documentation

• 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

3. Solution Design & Implementation

• 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

4. Testing, Validation & Support

• 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

5. Training & Knowledge Transfer

• 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

• 1-3 years of relevant experience
• Early-career or developing professional
• Works with moderate independence, often under guidance on complex initiatives
• Focus on building domain expertise and technical fluency

Clinical Systems Business Analyst (Mid)

• 3-6 years of progressive experience
• Mid-to-senior level practitioner with demonstrated independent delivery
• Leads workstreams and complex initiatives with minimal oversight
• Acts as a trusted advisor to stakeholders and clients
• Provides deeper clinical informatics expertise and leadership in solution design, * Bachelor's degree in Health Informatics, Clinical Research, Public Health, IT, or related field required
• Master's degree preferred (may substitute for experience)

Experience

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

Technical Skills (Both Levels)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
• Exposure to biomedical domains (e.g., oncology, imaging, pathology) is a plus

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

Preferred Qualifications

• 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 Additional Note

We are actively hiring for multiple positions at both Clinical Systems Business Analyst Jr. and Mid. Candidates will be assessed for the appropriate level based on experience, technical depth, and demonstrated leadership capability.

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

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.