Computer System Validation Remote Jobs in Reston, VA

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

Location: US Remote

Notice to Candidates: Employment in this position is expressly contingent upon Essex Management's receipt of a contract award from the Federal Government.

About Essex / Emmes Group

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.

• 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

• 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

• 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

• Bachelor's degree in Health Informatics, Clinical Research, Public Health, IT, or related field required
• Master's degree preferred (may substitute for 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

• BPMN, UML, workflow mapping, value stream mapping, FMEA, root cause analysis
• Microsoft Visio and similar tools

• EHR, EDC, CTMS platforms
• HL7, FHIR, CDISC, SNOMED, LOINC, OMOP
• Exposure to biomedical domains (e.g., oncology, imaging, pathology) is a plus

• Jira, Confluence, Azure DevOps
• SQL, Excel, Power BI, Tableau
• Configuration management and version control tools

• UAT support
• GxP / 21 CFR Part 11 / CSV validation experience
• Regulatory and audit readiness support

• 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

• 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

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.

Why work at Emmes?

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

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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