Professional Portfolio  ·  Pune, India

Rupesh Shinde

Enterprise Clinical Systems Product Manager

18+ years governing regulated Veeva Vault clinical platforms — CTMS, Study Startup and eTMF — across global pharma: product governance, validation, security and operational excellence. Hands-on with Applied AI — and moving from governing clinical systems toward leading Enterprise Healthcare AI & Digital Transformation.

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Pune, India · Onsite experience across the US & Europe Enterprise Pharma · Clinical Systems · Applied AI
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Rupesh Shinde — Enterprise Clinical Systems Product Manager
Rupesh ShindeEnterprise Clinical Systems Product Manager
18+
Years in healthcare technology
20+
Countries served at Novartis
40+
Global team members led
15–25%
Efficiency gains delivered
5+
Applied AI projects built hands-on
The Journey

A global career, across three continents

From an engineering degree in Pune to enterprise clinical platforms in New Jersey and Basel — and now governing global Veeva Vault clinical systems with hands-on Applied AI.

2007
Pune, India
B.E., Shivaji University — the foundation
2007–2021
New Jersey · Basel
Cognizant — 14 years of regulated delivery
2022–Now
Pune, India
Novartis — enterprise Veeva Vault CTMS product management
Professional Experience

Two decades building regulated healthcare technology

One continuous through-line — from large-scale clinical delivery, to governing a mature enterprise Veeva Vault platform, to hands-on Applied AI.

Current Role · 2022 – Present

Novartis — Enterprise Veeva Vault Clinical Product Management

Enterprise Clinical Systems Product Manager · Pune, India
  • Product owner for a mature enterprise Veeva Vault Clinical platform — CTMS, Study Startup and eTMF — used across 20+ countries: backlog and change-request governance, enhancement prioritization, and release coordination.
  • Drove continuous platform improvement and user adoption, contributing to 15–25% operational efficiency gains through process and workflow optimization.
  • Governed Computer System Validation (CSV/CSA) and the Veeva security matrix — role-based access and audit readiness — ensuring 21 CFR Part 11 and EU Annex 11 adherence.
  • Served as PQ business lead for platform releases, and evaluated AI use cases (Veeva AI PoC) for clinical documentation and eTMF — with a Responsible-AI lens.
Veeva Vault CTMS · SSU · eTMFProduct GovernanceGxP / CSV / CSA Security Matrix · RBAC21 CFR Part 11EU Annex 11AI PoC / Evaluation
Foundation · 2007 – 2021 · 14 Years

Cognizant — Regulated Delivery at Scale

Senior Technology Lead / Product Specialist · New Jersey, USA · Basel · India
  • Directed healthcare technology transformation for Fortune 500 pharmaceutical enterprises across the US, Europe and India.
  • Delivered and administered enterprise CTMS — including IMPACT CTMS (Parexel) — across 10+ simultaneous global programs for leading pharma organizations.
  • Led cross-functional delivery teams of 40+ members and governed CSV documentation, validation and EDC administration.
  • International Hackathon Finalist — presented clinical technology outcomes at Novartis Global HQ, Basel.

The IMPACT-to-Veeva span is a rare vantage point — I've operated both legacy and modern cloud CTMS, so I can speak to platform evolution, user workflows and validation effort from real experience.

IMPACT CTMS (Parexel)CSV / ValidationEDC · eTMF ETL PipelinesTeam LeadershipICH E6 GCP
Applied AI · Hands-on

Applied AI — Built in Practice

Independent, hands-on AI product work · Pune, India

Beyond governance, I build. I prototype and ship the AI healthcare workflows I evaluate at enterprise scale — proof my perspective on AI in clinical systems is grounded in real, working product, not slideware.

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Smiling HeartsLive

Healthcare web platform with a built-in compliance audit — privacy, consent & medico-legal readiness.

Orthopedic PlatformLive

Digital health platform — 40% new-patient growth, 4.9★ satisfaction.

Government SIR & Enumeration AutomationPilot

QR-based citizen data capture with automated reviewer & enumeration workflows.

MediScribeMVP

Ambient AI clinical documentation — SOAP notes, ICD-10 auto-coding & EHR integration.

ResQIn Dev

AI emergency coordination — triage, smart routing & offline-first critical care.

Credentials

Certifications & continuous learning

Tap any certificate to view it full size

Latest Certifications

All Certifications — hover to pause · click to enlarge

Core credentials

  • Certified Product Owner (Clinical Systems)Veeva Vault Platform · Oracle SQL · ITIL Foundation · Six Sigma Green Belt
  • GxP · CSV/CSA · 21 CFR Part 11 · EU Annex 11Regulated clinical platform validation & governance

Education

  • Bachelor of EngineeringShivaji University, India · Class of 2007
  • Continuous learningGenerative & Agentic AI, healthcare AI systems, enterprise transformation
Capabilities

Areas of expertise

01

Enterprise Product Management

  • Product Ownership
  • Product Governance
  • Backlog & Change-Request Management
  • Enhancement Prioritization
  • Release Coordination
  • Continuous Improvement
  • Stakeholder Management
  • Global Delivery
02

Clinical Systems

  • Veeva Vault CTMS
  • Study Startup (SSU)
  • Veeva Vault eTMF
  • IMPACT CTMS (legacy)
  • EDC
  • Clinical Operations
  • Clinical Trial Management
03

Validation & Compliance

  • CSV · CSA
  • Risk-Based Validation
  • UAT · Regression Testing
  • Release Validation
  • GxP Compliance
  • 21 CFR Part 11
  • EU Annex 11
  • ICH E6 GCP
04

Security & Administration

  • Veeva Security Matrix
  • Role-Based Access Control
  • User Access Management
  • Access Governance
  • User Administration
  • Audit Readiness
05

AI & Innovation

  • Applied AI (hands-on)
  • Agentic AI
  • NLP
  • Ambient AI
  • Enterprise AI Evaluation
  • AI Use-Case Identification
  • Responsible AI
Where I'm Headed

From Enterprise Clinical Systems Product Manager to Enterprise Healthcare AI & Digital Transformation Leader

The domain depth is built. The AI capability is hands-on and proven. The next chapter is leading the transformation itself — translating frontier AI into compliant, audit-ready platforms that move real clinical operations. Few people sit where regulated domain depth, hands-on AI delivery and global execution meet.

Regulated domain mastery

18+ years inside GxP-governed clinical systems — CTMS, Veeva Vault, CSV/CSA, 21 CFR Part 11 and EU Annex 11. I know where AI can — and cannot — be deployed in regulated pharma.

Hands-on AI delivery

I don't just sponsor AI — I prototype and ship it. Ambient documentation, agentic workflows, intelligent automation: from strategy deck to working product.

Global, audit-ready execution

Programs across 20+ countries and teams of 40+ — delivered on time, validated, and inspection-ready. Transformation that survives contact with regulators and operations.

Let's connect.

If you're shaping the future of regulated healthcare technology — or want a grounded view on where AI genuinely fits in clinical systems — I'd welcome the conversation.

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