Clinical Systems Business Analyst - Essex Management

Clinical Systems Business Analyst - Essex Mangement

US Remote

This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Clinical Systems Business Analyst is responsible for leading complex requirements elicitation, information modeling, and end-to-end process documentation to support the design, development, and optimization of biomedical and clinical informatics software and systems. This role partners closely with clinical, scientific, and technical stakeholders to support cancer research data repositories, interoperability platforms, and analytics-driven solutions. The Senior Analyst defines and prioritizes system requirements, translates clinical workflows into technical specifications, and provides strategic guidance to stakeholders to ensure solutions align with research objectives, regulatory standards, and institutional policies.

1. Serve as a primary liaison and trusted advisor to clinical research stakeholders and communities to analyze current-state workflows, operational challenges, and process constraints.
2. 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.
3. Independently gather, elicit, analyze, and document functional and non-functional requirements, ensuring all stakeholder perspectives are captured and cross-project communications remain aligned.
4. 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.
5. 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.
6. 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.
7. Identify pain points, bottlenecks, inefficiencies, and risk areas through direct workflow observation, data analysis, and collaborative discussions with end users.
8. 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.
9. Support data conversion, data mapping, and system integration activities related to clinical systems implementations and interoperability initiatives.
10. 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.
11. Design, develop, and deliver comprehensive training materials and conduct educational sessions to support end-user adoption, accommodating diverse learning styles and experience levels.
12. Provide post-implementation support and troubleshooting, ensuring sustained adoption, usability, and compliance with new tools and workflows.
13. Communicate effectively across all organizational levels, presenting findings, risks, and recommendations to frontline users, technical teams, and leadership.
14. Exercise strong independent judgment, balancing autonomous execution with appropriate escalation of risks, dependencies, or unresolved issues.
15. Actively contribute to strategic initiatives while supporting operational execution, ensuring timely and high-quality delivery of clinical informatics solutions.

Required Skills:

1. Advanced process documentation standards and methodologies
2. Use case and functional requirements documentation
3. Business and process modeling
4. Storyboarding and workflow visualization techniques
5. Unified Modeling Language (UML), Rational Unified Process (RUP), BPMN
6. Microsoft Visio (advanced proficiency)
7. Information Technology and data analysis expertise
8. Stakeholder engagement and client relationship management
9. Experience in Clinical Trials, Clinical Data Management, Health Information Exchange (HIE), interoperability initiatives, Life Sciences research (biomedical, genomics), or regulated pharmaceutical environments
10. Cancer research domain knowledge
11. Exceptional written and verbal communication skills
12. Knowledge of medical and scientific imaging (radiology, microscopy, pathology)
13. Knowledge of semantics, ontologies, and data standards supporting cancer research
14. Familiarity with data analysis and data visualization tools
15. Knowledge of program management and business analysis frameworks

1. 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
2. 3-5+ years of experience in a regulated IT environment (Pharma, GxP, federal or healthcare regulations) supporting clinical informatics or clinical research operations
3. Experience working in IT and data-driven environments, supporting system interoperability, implementations, change management, and business process redesign
4. Demonstrated expertise in process mapping, workflow analysis, and structured risk assessment methodologies (e.g., FMEA)
5. 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.
6. 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).
7. 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.
8. Proven ability to independently manage stakeholder engagement, translating between clinical, scientific, and technical audiences
9. High adaptability and rapid learning ability across new clinical, research, and technology domains
10. 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

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:

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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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