Trupti Shinde
Plainsboro,NJ
Summary
Seasoned IT Project Manager with over 15 years of experience leading complex, high-impact healthcare and life sciences technology projects. Demonstrated expertise in portfolio management, governance frameworks, client engagement, and cross-functional leadership. Proven track record of transforming delivery processes, optimizing costs, and driving alignment with organizational goals. Certified PMP and CQPA professional, skilled in Agile/Waterfall methodologies, risk management, and operational excellence.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr. Project Manager (Contract)
Zoetis Inc.
Parsippany, NJ
04.2025 - Current
- Led the end-to-end implementation of a validated Clinical Data Management System (CDMS) ensuring alignment with GxP, 21 CFR Part 11, and internal quality standards.
- Partnered with cross-functional stakeholders including Clinical Operations, Quality, Regulatory, and IT to define system requirements, establish governance, and ensure project alignment with business objectives.
- Vendor relationships for system configuration, integration, and validation deliverables, ensuring contractual adherence and on-time delivery.
- Developed and maintained a comprehensive project plan covering scope, schedule, budget, and resource allocation; tracked progress through KPIs and performance metrics.
- Conducted risk assessments and implemented proactive mitigation strategies to minimize project delays and compliance risks.
- Facilitated training and change management activities to ensure successful user adoption across global teams.
- Oversaw the creation and execution of validation documentation including User Requirements Specifications (URS), IQ/OQ/PQ testing, and traceability matrices.
- Delivered executive-level reports on project health, budget forecasts, and quality metrics to key sponsors and governance boards.
- Collaborated with Quality and Compliance teams to ensure audit readiness and complete documentation per CSV/CSA principles.
Program Manager (QMS)
Envision Pharma Group
Fairfield, CT
01.2021 - 05.2024
- Implemented the iEnvision enterprise digital medical affairs platform (SaaS) for clients and integrated it with ERP systems enabling real-time data sharing and consolidated reporting on medical affairs activities.
- Led project managers in developing automated processes that seamlessly integrated medical affairs data with financial and operational metrics, resulting in a 30% improvement in operational efficiency.
- Conducted audits ensuring compliance with GAMP, ISO 13485, and 21 CFR Part 11.
- Proven ability to lead SysOps, DevOps, and Data teams supporting 80+ global life science clients.
- Generated actionable insights on stakeholder engagement and improved communication effectiveness by 50%.
- Developed and implemented comprehensive project plans encompassing detailed timelines, resource allocation, and budget forecasting. This strategic approach streamlined workflows, resulting in a 25% increase in efficiency for regulatory submission processes.
Quality Improvement Program Manager (PMO Lead)
Envision Pharma Group
Fairfield, CT
01.2020 - 12.2020
- Led PMO training sessions on Project Management Best Practices with a focus on risk management.
- Introduced Agile MVP approach, reducing project costs by 25% while maintaining quality outcomes.
- Led the migration of 100+ on-premises servers to AWS, achieving high availability and optimal resource utilization, enhancing operational scalability.
- Presented program updates, risk registers, and financial metrics to C-Suite, ensuring informed decision-making.
- Implemented a robust vendor management strategy, optimizing vendor selection and collaboration.
Delivery Program Manager (PMO Member)
Envision Pharma Group
Fairfield, CT
01.2016 - 12.2019
- Managed global teams of 20+ members across client delivery projects, aligning with scope, schedule, and cost constraints.
- Developed communication strategies to maintain strong client relationships, ensuring business continuity.
- Conducted workshops with clinical staff, regulatory personnel, and IT teams to align technology solutions with business needs.
Validation Project Manager
Envision Pharma Group
Fairfield, CT
01.2014 - 12.2015
- Managed multiple complex validation projects simultaneously.
- Developed robust change control procedures to document and control project scope adjustments.
- Authored Audit Plans, Validation Master Plans, Protocols, and Final Validation Reports.
Project Manager
Genzyme Corporation
Cambridge, MA
08.2012 - 08.2013
- Oversaw IT project planning, execution, and delivery, managing risks and implementing mitigation strategies.
Senior Project Manager (Contract)
Eliassen Group
New London, CT
03.2011 - 08.2013
- This was a contract position to lead projects listed below:
Training Program Manager
Pfizer Inc
Groton, CT
03.2011 - 08.2012
- Implemented and maintained the Learning Management System (LMS) to meet FDA and EMA compliance.
- Designed compliance-focused training programs for cross-functional teams.
Education
Postgraduate Degree in Law (LL. B) -
University of Pune
IndiaBachelor of Arts in Economics (B.A.) - undefined
University of Pune
IndiaSkills
- Portfolio Management & Strategic Planning
- Delivery Excellence & Governance Leadership
- Client Relationship & Stakeholder Engagement
- Risk Mitigation & Change Management
- Financial Planning & Cost-of-Delivery Optimization
- Expertise in ITIL framework and best practices Healthcare & Life Sciences
- Pre-Sales Support & Solution Consultation
- Cross-Functional Collaboration & Team Leadership
- Agile/Waterfall Methodologies
- Microsoft Office 365 – Excel, MS Project, PowerPoint, SharePoint, Teams
- Atlassian & Project Management tools - Confluence, Jira Service Management, Trello, Smartsheet, Workfront
- Enterprise Resource Planning (ERP) and Business Platforms: Microsoft Dynamics 365, Veeva Vault, Oracle ERP, SAP
- Quality and Compliance Tools: TrackWise, Veeva Vault QualityDocs
- Data Visualization and Analytics: Power BI
Certification
- Project Management Professional (PMP) – PMI
- Certified Quality Process Analyst (CQPA) – ASQ
- Lean Six Sigma Green Belt – Six Sigma Academy Amsterdam (Ongoing)
Timeline
Sr. Project Manager (Contract)
Zoetis Inc.
04.2025 - Current
Program Manager (QMS)
Envision Pharma Group
01.2021 - 05.2024
Quality Improvement Program Manager (PMO Lead)
Envision Pharma Group
01.2020 - 12.2020
Delivery Program Manager (PMO Member)
Envision Pharma Group
01.2016 - 12.2019
Validation Project Manager
Envision Pharma Group
01.2014 - 12.2015
Project Manager
Genzyme Corporation
08.2012 - 08.2013
Senior Project Manager (Contract)
Eliassen Group
03.2011 - 08.2013
Training Program Manager
Pfizer Inc
03.2011 - 08.2012
Bachelor of Arts in Economics (B.A.) - undefined
University of Pune
Postgraduate Degree in Law (LL. B) -
University of Pune