CLINICAL BUSINESS ANALYST JOB DESCRIPTION

A Clinical Business Analyst translates what clinical end users need into requirements a development team can build and validate. This means owning the gap between oncology workflows and IT systems - conducting stakeholder interviews one day and reviewing business requirements documents the next. The role operates within regulated environments where HIPAA compliance and clinical trial management standards define what acceptable looks like. Expectations here are concrete: requirements must be traceable, acceptance criteria must hold under UAT, and nothing ships without sign-off from the right stakeholders.

As the Clinical Business Analyst, you convert clinical stakeholder needs into structured, validated requirements that drive product and system development across healthcare and life sciences organizations. The role spans multiple internal teams - including clinical operations, IT, and product development - and reports into either an IT Director or a Clinical Business Operations Manager depending on organizational structure.

Career Impact: Deep experience gathering requirements against FDA-regulated clinical systems and CTMS environments builds the kind of domain credibility that is difficult to replicate in generalist BA roles.

Business Impact: When requirements are incomplete or misaligned, clinical software fails validation - this role is the checkpoint that keeps development on track and compliant before products reach clinical sites.

Growth Opportunity: The analytical and regulatory depth developed here opens paths toward Senior BA, Product Owner, or Clinical Project Manager roles in pharmaceutical and health technology organizations.

• Interview clinical end users, sponsors, and stakeholders to capture business, functional, and technical requirements for software and system initiatives.
• Translate gathered requirements into user stories, acceptance criteria, BRDs, process flowcharts, and technical specifications for development teams.
• Monitor project scope, identify blockers affecting timeline or cost, and escalate risks to appropriate stakeholders before they affect delivery.
• Analyze and document clinical business processes by constructing data models, interface navigation maps, and reporting requirements to support system design.
• Collaborate with clinical operations, IT, and product teams to ensure requirements align with strategic objectives and regulatory compliance standards.
• Support user acceptance testing by coordinating sessions with clinical stakeholders and verifying that delivered functionality meets documented requirements.
• Develop and track KPIs across clinical project performance dimensions, including outreach, data operations, and coding, to surface issues early.
• Present analytical findings, recommendations, and system concepts clearly to non-technical clinical and operational audiences.

• Bachelor's degree in business, health informatics, computer science, or a related field, or equivalent work experience.
• 3 or more years of business analysis experience in a healthcare or life sciences environment, with demonstrated ownership of requirements through UAT.
• Familiarity with healthcare compliance frameworks, including HIPAA and clinical trial data governance requirements.
• Proven ability to construct process models, flowcharts, and structured requirements documents from complex stakeholder input.
• Strong verbal and written communication skills, with the ability to present technical design decisions to non-technical audiences.
• Analytical and quantitative aptitude, including experience with data mining, KPI development, and structured problem-solving.
• Ability to manage multiple concurrent requirements workstreams within timeline and resource constraints.

• Experience with clinical trial management systems, electronic data capture platforms, or health IT integration standards such as HL7.
• Familiarity with agile delivery practices, including backlog grooming, sprint ceremonies, and story prioritization alongside development teams.
• Exposure to oncology, hematology, or life sciences clinical operations, including study design and Clinical Value Chain concepts.
• Certifications in project management, business analysis, or process improvement disciplines such as PMP, Lean/Six Sigma, or Agile.

• Requirements traceability rate, measuring the percentage of delivered features linked to documented and approved specifications.
• UAT pass rate on first submission, indicating how thoroughly requirements were validated before development handoff.
• Stakeholder sign-off cycle time, reflecting how efficiently requirements move from draft to approved status.
• KPI compliance rate across monitored clinical project dimensions, showing how closely performance tracks against defined targets.
• Defect rate attributable to requirements gaps, measuring downstream development rework tied to this role's output.
• Typical tools: requirements and backlog management (commonly JIRA or equivalent); reporting and analytics (commonly SQL-based tools or BI platforms).

• Base Salary Range: $75,000 to $105,000 annually, depending on experience and location.
• Bonus: Annual performance bonus, typically 5% to 10% of base salary.
• Equity: Uncommon at this level; offered occasionally at health tech companies.
• Health Benefits: Medical, dental, and vision coverage; standard US employer plan.
• PTO: 15 to 20 days annually, plus federal holidays.
• Common Perks: Continuing education reimbursement, remote or hybrid work options, professional certification support.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Candidates requiring reasonable accommodations during any stage of the application or interview process may request them at any time. Final offers are contingent on successful completion of a background check, which may include criminal history and employment verification. All applicants must be authorized to work in the United States.

The Clinical Business Analyst owns the full product development lifecycle for Clinical Studio products, translating product strategy into detailed requirements and user stories that enable AI and engineering teams to deploy Digital Pathology algorithms on the Navify platform. Reporting to the Product Manager and working alongside Development and Technical Leads, this role ensures backlog prioritization, scope decisions, and release readiness stay aligned to strategic objectives.

Key Responsibilities

• Translate product strategy into detailed requirements for prototype construction and final product development.
• Be the voice of the customer for the product development team throughout the entire product development lifecycle, from definition to sunsetting of the product.
• Collaborate with customers, team members, and outside influencers to ensure a solid and well-rounded understanding of products and developing needs.
• Be the high-availability resource for answering questions posed by engineers, data scientists, and designers about stories in the backlog on a day-to-day basis.
• Author user stories, acceptance criteria, product, and software requirements documentation.
• Ensure that story content and prioritization is aligned to larger strategic objectives.
• Attend standups, grooming meetings, estimation meetings, retrospectives, and other key meetings for the scrum team.
• Manage scope and drive trade-off decisions in conjunction with external stakeholders.
• Identify blockers that will impact timeline, scope, cost, or other project variables and escalate to the appropriate stakeholders.
• Manage requirements lifecycle across multiple tools and systems.
• Support user acceptance testing activities by interacting with stakeholders.
• Prepare release notes and update business owners regarding features being incorporated in each release.

Required Qualifications

• Bachelor's degree or equivalent practical experience.
• High school diploma or GED with 2 years of experience, or Associate's degree required.
• 1–2 years of experience delivering technology-powered products as a product business analyst, data analyst, data scientist, or user researcher.
• 3 years of experience preferred.
• Healthcare technology experience is a plus.
• Knowledgeable in technology trends and excited to help craft the future of healthcare.
• Ability to lead cross-functional teams of engineers, designers, and researchers in a constructive and collaborative relationship.
• Ability to engage with functional areas outside of product development, including finance, legal, compliance, or marketing.
• Ability to figure out solutions to hard problems with many constraints using sound judgment to assess risks and lay out arguments in a well-structured, data-informed written narrative.
• Strong communication skills, including the ability to speak clearly to a group of people.
• Able to maintain both short-term in-depth focus and long-term strategic vision for the product.

Embedded within the IT department, the Clinical Business Analyst delivers integrated software solutions that align technology systems with business operations, spanning Real World Data, AI applications, and clinical trial management systems for oncology programs. Working closely with collaborators, vendors, internal departments, and clinical sites, this role builds internal IT support capacity and drives web-based service performance across the Coalition and its affiliated entities.

Core Functions

• Perform system analyses on software programs, applications, and web services and make recommendations for necessary changes or upgrades.
• Act as the liaison with collaborators and vendors, internal departments, and clinical sites to ensure system viability and user familiarity and proficiency.
• Work with staff to develop and deliver all appropriate and necessary reports.
• Work with key departments to ensure and maintain relevant efficiencies within the system.
• Assist management with identifying areas of improvement and enhancements and obtain approval for system development projects.
• Efficiently integrate new systems, programs, and applications with business operations and services.
• Analyze and improve the performance of web-based customer portals and support services.
• Monitor product licenses and ensure compliance with IT industry regulations.
• Ensure that computer hardware remains compatible with system enhancements and updates.
• Participate in ongoing continuing education courses or seminars.

Qualifications & Experience

• Bachelor's degree with a major in computer science, electronics, or management information systems, or relevant professional experience required.
• An accreditation in management consultancy.
• Minimum of 5 years of experience in computer systems programming, operations, systems, database or network enterprise system support, or information technology management consulting.
• Experience working in a clinical trial environment.
• Extensive experience in technical business analysis in a related industry.
• Knowledge of a CTMS or CTMF.
• Knowledge of clinical database study build is a plus.
• Advanced knowledge of programming languages such as SQL and MS Access, and system integration solutions.
• Advanced knowledge of data security and encryption.
• Able to facilitate internal end-user proficiency.
• Able to design and maintain efficient customer portal support and feedback channels.
• Able to keep up with IT advancements.
• Knowledge of relevant licensing and industry compliance regulations.
• Exemplary interpersonal, communication, and education skills toward facilitating the use of new software systems.
• Self-directed, motivated, organized, with strict attention to detail and strong problem-solving and decision-making abilities.

Reporting to product and technology leadership, the Clinical Business Analyst shapes requirements across the full software development lifecycle, translating clinical end-user and stakeholder needs into prioritized user stories and functional specifications aligned to business and customer goals. Partnering with offshore development and QA teams, cross-departmental leads, and product owners, this role advances product outcomes in healthcare clinical supply chain and acute care workflow environments.

Primary Duties

• Provide expertise in focused areas of the business through analysis and understanding of business needs.
• Interact with clients and stakeholders to understand and capture their functional and technical requirements.
• Apply a fundamental knowledge of a business area's processes and practices to optimize or solve new business challenges.
• Interact with teams to determine project requirements, business issues, and make recommendations based on systems and best practices.
• Analyze and document business, user, and detailed functional requirements and ensure alignment to business and customer goals and objectives.
• Develop and assist in grooming and prioritizing user stories in the product backlog.

Skills & Qualifications

• Bachelor's degree from an accredited university.
• Minimum of 5 years of related work experience as a Business Analyst, Product Owner, or Product Manager in a software environment, or equivalent combination of education and experience required.
• Work experience in a software development or technology environment required.
• Work experience in healthcare strongly preferred.
• Experience in Healthcare Clinical Supply Chain Management strongly preferred.
• Experience in acute care clinical workflows strongly preferred.
• Experience interacting at high levels with multiple departments to determine product requirements and customer needs.
• Ability to work with offshore development and QA teams, recognizing the time zone challenges of an offshore team.
• Experience with Jira, Aha!, or equivalents highly preferred.
• Strong analytical skills, work ethic, problem-solving ability, and positive attitude.
• Strong leadership skills and ability to work both autonomously and as a team player with thoroughness and accuracy.
• Excellent oral and written communication skills.
• Problem-solving oriented, with a constant desire to improve and achieve higher standards.

Sitting at the intersection of clinical operations and data-driven project delivery, the Clinical Business Analyst leads implementation and performance monitoring for Health Risk Assessment client projects, building KPIs across outreach, coding, data operations, and clinical services. Operating across account management, vendor relationships, and departmental leads, this role ensures HRA project forecasts, staffing targets, and client expectations are consistently met or exceeded.

Duties

• Collaborate with the Clinical Business Operations Manager to lead the implementation process for assigned HRA projects, including the gathering of client requirements and collaboration with internal teams to launch new projects in an efficient and cost-effective manner.
• Develop and monitor HRA project delivery forecasts and provider staffing targets for assigned HRA projects to meet or surpass client goals.
• Develop and monitor KPIs for all facets of HRA project performance across outreach, coding, data operations, and clinical services for assigned HRA projects, escalating performance issues to relevant departmental leads and to the Manager and Director of HRA Operations.
• Interface with leads of all HRA-related teams on a weekly basis to ensure successful project implementation and delivery for assigned HRA projects.
• Interface with account management and client stakeholders on a weekly basis, or as needed, to present project performance, address client requests, and ensure client expectations are met or exceeded.
• Collaborate with the Manager and Director of Clinical Business Operations to manage vendor relationships for HRA business, including third parties providing lab, diagnostic, and staffing services.
• Maintain the ability to work in an environment with PHI and PII data.

Requirements

• Bachelor's degree in Finance, Business, Industrial Engineering, or related field required.
• 2 or more years of work experience in operations management, preferably within healthcare services.
• Knowledge of HIPAA compliance rules and regulations a plus.
• Proficiency with MS Office and G-Suite required.
• Proficiency with MS Excel required, with exceptional MS Excel skills strongly preferred.
• Experience with analytics-based coding languages such as SQL or Python strongly preferred.
• Must be able to work under pressure and meet deadlines while maintaining a positive attitude and providing exemplary customer service.
• Ability to work independently and in teams to carry out assignments to completion within prescribed parameters and standard accepted practices.
• Strong time management skills and ability to prioritize workloads.
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external customers.
• Strong interpersonal and client management skills.
• Must be organized and detail oriented.
• Must be able to talk, listen, speak, and view as required to read printed and electronic material.

A key member of cross-functional project teams, the Clinical Business Analyst builds the requirements documentation, process models, and validation frameworks that translate clinical end-user needs into business, functional, and technical specifications across complex healthcare technology implementations. Collaborating with Systems Analysts, project managers, vendors, and clinical stakeholders, this role produces the test plans, training materials, and prototypes that guide successful system delivery and adoption.

Functions

• Interview users, stakeholders, and sponsors to assess departmental needs and create business, functional, and technical requirements documents.
• Develop documentation of test plans, technical documentation, release notes, end-user guides, training programs, and other materials as necessary.
• Analyze and document client business requirements and processes and communicate requirements to technical personnel by constructing basic conceptual data and process models, including process flowcharts and technical specifications.
• Decompose information gathered into details, including sources of data, data types, users, user types, interface components, interface navigation needs, reporting needs, and administrative system needs.
• Present concepts in a concise and focused manner, including narrative, process diagrams, role and accountability diagrams, and business-focused storyboards.
• Research industry practices, collect and analyze data, draw appropriate conclusions and recommendations, and present results in written reports or oral presentations using visual aids.
• Coordinate user groups and project teams, convene conference calls and meetings, and maintain minutes and follow-up logs.
• Work collaboratively with the Systems Analyst to develop designs, mockups, and prototypes.
• Communicate technical design issues to non-technical people.
• Provide ongoing communication with users, managers, corporate directors, and vendors to assure support and current initiatives.

Experience & Qualifications

• Bachelor's degree in a related field required.
• Experience with Kronos or Clair-via preferred.
• Experience with HL7 communications preferred.
• Experience working in a Project Management Office with cross-functional teams is a plus.
• Experience scheduling, specifically nurse or healthcare scheduling, is a plus.
• Experience training personnel is a plus.
• Ability to work independently and as part of a fast-moving team.
• Ability to lead business in programs with complex projects.
• Ability to work within the timeline and resource constraints provided by the Project Manager.

Accurate benchmarking and portfolio performance tracking across Clinical Development depend on the Clinical Business Analyst, who partners with technical teams to build analytics, visualizations, and KPI frameworks that compare operational performance against industry standards. Based within the Clinical Portfolio and Capacity Management function, this role serves as an internal consultant to senior leadership and cross-functional stakeholders, supporting protocol optimization and change management across global clinical programs.

Accountabilities

• Work closely with key stakeholder functions and leadership to identify and address data analytics, visualization needs, and sources of data.
• Partner with technical teams to develop insightful, accurate analytics and visualizations to identify trends, exceptions to KPIs, and ensure escalation of risks.
• Act as internal consultant for industry benchmarks across Clinical Development.
• Identify and analyze relevant metrics and KPIs to compare current performance to industry benchmarks.
• Monitor and evaluate data to identify how closely actual performance complies with defined KPIs.
• Collaborate with other members of Clinical Portfolio and Capacity Management to support portfolio performance tracking and reporting.
• Support protocol optimization by leveraging global health research network and patient burden algorithm tools.
• Act as a change agent to articulate intent, drive awareness, and support communications and training to ensure effective adoption and utilization of system and process improvements.

Technical Qualifications

• Bachelor's degree in business administration, finance, science, or a related field.
• Minimum 6 years of experience in life sciences or a related industry.
• Oncology or hematology experience preferred.
• Significant knowledge of clinical development planning, management, and reporting systems.
• Strong analytical and quantitative skills.
• Experience with data mining and preparation for review.
• Proficient in the use of enterprise project management, business intelligence, and reporting tools.
• Knowledge of industry trends, competition, and current and emerging technologies.
• Strong verbal and written communication skills, effective in cross-functional interaction and with senior management.
• Ability to work independently in a rapidly changing environment.
• Excellent judgment and problem-solving skills.
• Ability to think creatively, strategically, and tactically.
• Demonstrated success in establishing working relationships with a diverse range of internal and external stakeholders.

As the Healthcare/Clinical Business Analyst, this role leads application consulting and solution delivery for pharmaceutical organizations across the full Clinical Value Chain, encompassing eTMF, CTMS, EDC, and decentralized clinical trial systems. The Clinical R&D practice relies on this work to drive process optimization, change management, and strategic alignment between business objectives and system requirements at the Director and Senior Director level.

Operational Focus

• Implement solutions and deliver application consulting for pharmaceutical organizations in the clinical space.
• Aid in the development of new solutions and consulting methods and contribute to solution design and delivery activities.
• Guide customers in testing of workarounds, clinical integration, and new functionality.
• Maintain functional and technical understanding of clinical applications and systems such as eTMF, CTMS, and EDC.
• Analyze the customer's existing business workflows and facilitate proper change management in the clinical or operational environment.
• Provide horizontal consulting in life sciences.
• Provide leadership, strategic direction, and technical expertise on process optimization and improvement services.
• Continuously improve business processes by facilitating strategy development and adopting best practices to align processes toward the Business Excellence Model.

Position Requirements

• Master's degree or MBA strongly preferred.
• Certifications in Lean/Six Sigma, PMP, or Agile preferred.
• 8 or more years of experience in the Clinical R&D industry.
• Experience translating business objectives to system requirements.
• Experience leading strategic and tactical discussions with Director and Senior Director level stakeholders.
• Exposure and hands-on understanding of the Clinical Value Chain, including Clinical Data Management, Clinical Operations, Electronic Data Capture, Decentralized Clinical Trials, Clinical Supply Chain, or Analytics and automation.
• Knowledge and work experience in one or more of the following: Clinical Operations, Clinical Data Management, Clinical Analytics, Clinical SAS, or Study Data Tabulation Model.
• Understanding of ICH, Google Cloud Platform, US-FDA, and EMA guidelines.