Summary
Work History
Education
Skills
Personal Information
Timeline
Generic

Sireesha G

Santa Clarita

Summary

Owns product vision, roadmap, and backlog for clinical trial applications. with focus on AI model optimization and performance tuning. Translates clinical and business needs into clear requirements, user stories, and acceptance criteria; partners with engineering through Agile delivery and validated releases (CSV, 21 CFR Part 11); acts as Subject Matter Expert in client consultations explaining AI mechanics and defensibility; and aligns global business, clinical operations, and technology stakeholders on priorities and trade-offs.

Work History

Manager Compliance

BeOne
  • Drive cross-functional R&D initiatives from planning through delivery, managing scope, timelines, milestones, dependencies, and outcomes with focus on AI integration and optimization strategies.
  • Identify and track project risks, issues, and action plans ensuring timely resolution, escalation, and stakeholder alignment; monitor AI model performance and accuracy metrics for compliance in regulated environments.
  • Drive collaboration across R&D and Technology teams to deliver process improvements, system enhancements, automation, AI-driven solutions, and new capabilities aligned with regulatory requirements.
  • Establish project KPIs including AI usage and accuracy metrics, dashboards, RAID logs, status reporting, and governance routines to support leadership decisions and ensure AI auditability.
  • Coordinate stakeholders across R&D functions, facilitate planning and decision-making on AI tool adoption and implementation, manage priorities and dependencies, and drive teams toward successful delivery.
  • Work independently and with global teams, covering extended hours to support U.S. Eastern time collaboration; provide technical training and consultation on Generative AI mechanics and defensibility.
  • Designed and implemented client-specific solutions supporting complex litigation and investigation workflows across the full eDiscovery reference model.
  • Demonstrated extensive knowledge of legal case management systems and litigation lifecycle through end-to-end product strategy and delivery.
  • Communicated advanced ML concepts including model drift and hallucination risks to C-Suite and client audiences in clear, non-technical business language.
  • Analyzed off-the-shelf eDiscovery and AI tools to evaluate capabilities and make recommendations for new platform offerings and implementations.
  • Explained confidence scoring and related AI model uncertainty metrics to stakeholders to ensure defensible deployment of predictive algorithms.
  • Acted as Subject Matter Expert in direct client consultations, explaining AI mechanics, defensibility, and limitations to build trust and drive adoption.

Technical Business Analyst

Amgen
  • Supported Clinical Statistical Programming, EDC and Clinical Operations technology products end to end, owning scope, priorities, timelines, dependencies, and risks across multiple applications; integrated and optimized Generative AI models within clinical workflows.
  • Supported Electronic Data Capture (EDC) migration project to Veeva Vault platform and served as the key liaison between business and technology teams, translating business needs into requirements, user stories, and acceptance criteria aligned to strategic priorities and AI integration strategies.
  • Led Agile delivery across the SDLC including sprint and release planning, backlog prioritization, stand-ups, product demos, and retrospectives while meeting quality and CSV requirements; ensured AI model outputs were transparently logged and auditable.
  • Managed planning, tracking, and reporting in Jira, Confluence, Smartsheet, Tableau, and Power BI to monitor product health, KPIs including AI accuracy and usage metrics, milestones, and executive status.
  • Managed governance and change: RAID logs, stakeholder communications, and leadership reporting to keep delivery on schedule.
  • Applied Generative AI and automation tools including prompt engineering strategies with Microsoft Copilot and ChatGPT to streamline documentation, workflows, and reporting; tested and refined advanced AI prompts to maximize accuracy and efficiency.

IS Systems Business Analyst

Amgen
  • Led change enablement for EDMQ and TMF implementations in Veeva Vault including rollout plans, readiness assessments, technical training on AI tool usage, and adoption activities.
  • Supported eTMF migration to Veeva Vault (CDOCS) coordinating requirements for document lifecycles, workflows, security, reports, document types/subtypes, and metadata for R&D functions; ensured compliance with EDRM standards and eDiscovery protocols.
  • Served as the voice of the customer and Subject Matter Expert in client consultations: gathered feedback on AI tool mechanics and defensibility, documented business requirements, refined user stories and acceptance criteria, and prioritized capabilities by business value.
  • Coordinated testing, UAT, deployment, and release readiness for Veeva Vault enhancements and migrations including AI model integration and validation, tracking defects, decisions, and business readiness through go-live.
  • Aligned business, technology, Quality, and vendor teams on scope, timelines, dependencies, and risks including AI tool implementation; reported project health, milestones, and AI usage metrics to leadership.

Associate Project Manager / Business Analyst

Amgen
  • Managed end-to-end StarLIMS application projects covering requirements, schedules, releases, enhancements, integrations, and change requests across onsite and offshore teams; analyzed tool capabilities for AI optimization opportunities.
  • Partnered with laboratory, Quality, and technology stakeholders to turn business needs into functional requirements, user stories, workflows, and implementation plans; recommended new AI-augmented offerings for current workflows.
  • Led Agile/Scrum delivery including sprint and release planning, backlog refinement, product demos, UAT coordination, and retrospectives; integrated and optimized Generative AI models within custom workflows.
  • Supported validated system delivery including 21 CFR Part 11, GxP, change control, testing, IQ/OQ/PQ, and release readiness; designed and implemented technical framework for AI Auditability Protocol ensuring transparent logging of all ML and Generative AI outputs.
  • Tracked milestones and project health with Jira, Smartsheet, Microsoft Project, SharePoint, Power BI, and Tableau including AI model performance metrics; resolved competing priorities and mitigated risks through to operational transition.

IS Business Analyst

Biogen
  • Supported Research LIMS applications defining and managing epics, user stories, and acceptance criteria across the project lifecycle; evaluated AI-driven enhancements for data analysis and workflow optimization.
  • Documented business process workflows and data flow diagrams; wrote SQL queries for data profiling and validation; applied data analysis techniques to support machine learning model evaluation.
  • Delivered QA support including authoring and executing test cases for AI model performance, coordinating defect triage, and facilitating UAT to ensure AI output accuracy and auditability.

IS Business Analyst

Novartis
  • Supported TrackWise quality processes with quality and manufacturing teams managing deviation investigations, corrective actions, process validation, and GxP documentation within regulated healthcare environments.
  • Led QA planning and execution including test plans and cases for AI model validation, functional integration, regression and UAT cycles, and defect triage; produced periodic status reports tracking AI performance metrics and auditability.

Education

MBA -

California Lutheran University

MS -

London Metropolitan University

Skills

  • Regulatory: Prompt engineering, Python, Data analysis, Large language models, Machine learning, Generative AI, AI model optimization, AI Auditability Protocol, GxP, Jira, Confluence, Smartsheet, Tableau, Power BI, SQL, Python, Microsoft Copilot, ChatGPT, Veeva Vault, StarLIMS, TrackWise, Veeva, R, Relativity aIR, eDiscovery AI, priorities, and risks across multiple applications EDMQ, EDC (Veeva Vault), Product vision and strategy, roadmap planning, backlog prioritization, epics/user stories/acceptance criteria, release planning, stakeholder management, KPIs and adoption metrics, 21 CFR Part 11, Computer System Validation (IQ/OQ/PQ), change control, audit and inspection readiness, technical communication, leadership, stakeholder management, AI usage metrics tracking
  • IQ/OQ/PQ
  • UAT
  • 21 CFR
  • CSV
  • Part 11
  • 21 CFR Part 11
  • Change control
  • Audit and inspection readiness
  • Tools: Jira
  • Confluence
  • Smartsheet
  • Tableau
  • Power BI
  • SQL
  • Microsoft Copilot
  • ChatGPT
  • Veeva Vault
  • StarLIMS
  • TrackWise
  • R
  • Microsoft Project
  • SharePoint
  • Jira
  • Tableau, Power BI, SQL, Python, Microsoft Copilot, ChatGPT, Veeva Vault, StarLIMS, TrackWise, Veeva, R, Relativity aIR, eDiscovery AI platforms

Personal Information

Title: Product Manager, Clinical Trial Technology

Timeline

Manager Compliance

BeOne

Technical Business Analyst

Amgen

IS Systems Business Analyst

Amgen

Associate Project Manager / Business Analyst

Amgen

IS Business Analyst

Biogen

IS Business Analyst

Novartis

MBA -

California Lutheran University

MS -

London Metropolitan University
Sireesha G