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Nikhilesh Siddanthi

@nikhileshsiddanthi

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Senior Business Analyst specializing in regulated healthcare technology and compliant clinical data platforms.

India

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What I'm looking for

I’m looking to build medical-grade, compliance-first data management products—translating regulated requirements into clear backlogs, driving validation-ready documentation, and partnering across clinical, regulatory, and engineering teams to ship audit-ready systems.

I’m a Senior Business Analyst with 12+ years of experience delivering regulated healthcare and life sciences technology products across clinical trials, regulatory affairs, and medical imaging data domains. I translate complex regulatory requirements—including FDA 21 CFR Part 11, GxP, CE marking, MDD, and GCP—into actionable product backlogs and compliant, audit-ready systems.

At Space Inventive (Novartis Digital Programs), I led product definition for CDE submission software and clinical data management platforms supporting Large Volume Injection (LVI) trials and EDC workflows, managing cross-functional teams of 15+ across engineering, clinical operations, and regulatory affairs. I drive the full lifecycle from conceptual design through system testing and market launch, using Agile and DevOps/CI-CD practices with hands-on ALM tool experience (JIRA, Azure DevOps) to build medical-grade data management systems that improve patient outcomes.

Experience

Work history, roles, and key accomplishments

Senior Business Analyst

Space Inventive

Jun 2024 - Feb 2025 (8 months)

Performed detailed gap analysis between NMPA/FDA regulatory guidelines and software capabilities to draft functional specifications for Novartis CDE submission software, achieving 100% compliance. Translated regulatory mandates into clinical data management requirements aligned to 21 CFR Part 11 and GCP, authoring FRS/URS and traceability matrices to support GxP validation (IQ/OQ/PQ) and audit-rea

Regulatory Compliance GCP Clinical Data Management GxP Validation UAT Agile Scrum

Senior Business Analyst

Realpage

Apr 2023 - Dec 2023 (8 months)

Owned product backlog planning and release readiness by prioritizing agile feature delivery and maintaining sprint cycles. Used Azure DevOps to manage project lifecycles and repo hygiene, and applied data-driven query analysis to refine backlog prioritization and feature decisions.

Agile Scrum Backlog Management Release Management Azure DevOps Data Analysis Product Management Cross Functional Collaboration

Lead Business Analyst

H1 Insights

May 2021 - Dec 2022 (1 year 7 months)

Translated business objectives into functional requirements for a web-based HCP search platform, managing requirements from ideation through go-live. Conducted market research and gap analysis to drive a prioritized roadmap, defined user acceptance criteria, and designed data mapping/standardization logic for integrating large healthcare datasets into cloud storage for searchable onboarding workfl

Product Requirements Market Research Gap Analysis User Acceptance Data Mapping Data Standardization Data Integration Stakeholder Management

Lead Business Analyst & Product Owner

Franklin Templeton

Feb 2019 - May 2021 (2 years 3 months)

Managed the end-to-end requirements lifecycle in JIRA by writing user stories and acceptance criteria, running backlog refinement, and facilitating agile ceremonies to resolve ambiguities and prevent scope creep. Coordinated product roadmaps for healthcare software, conducted user research and usability testing to drive improvements, and delivered product demonstrations and training for end users

Jira User Stories Acceptance Criteria Agile Ceremonies Product Roadmapping User Research Stakeholder Management Product Demonstrations

Lead Business Analyst

Deloitte

Jun 2016 - Feb 2019 (2 years 8 months)

Collaborated with cross-functional teams to develop and implement product roadmaps for healthcare software, ensuring requirements, user stories, and acceptance criteria aligned to stakeholder needs and delivery timelines. Conducted user research and usability testing to inform product improvements, and supported end-user adoption through demonstrations and training.

Product Roadmapping Requirements Gathering User Stories Acceptance Criteria User Research Usability Testing Product Demonstrations

Business Analyst

Caliber Technologies

Dec 2012 - Apr 2016 (3 years 4 months)

Conducted market research and competitive analysis to support product strategy and identify growth opportunities. Developed business cases and product specifications, worked with engineering on requirements/user stories/acceptance criteria, and delivered end-user demonstrations and training to support adoption.