Sourav Gupta
MBA, BS
With 20+ years of experience across Life Sciences, MedTech, Digital Health, and IT/Software industries, I bring deep expertise in program and project management, regulatory consulting, business operations, and digital transformation. My career has encompassed advisory, consulting, service delivery management, product management, and leadership roles. I have successfully led complex programs, built high-performing cross-functional teams, and consistently delivered results that exceed expectations, driving innovation and operational excellence.
Certifications
Diversity of Experiences
- Client Delivery Management: Spearheaded large-scale consulting and digital transformation programs for high-profile clients in the life sciences and medical devices sectors, including Cardinal Health, Johnson & Johnson, Bausch Health, Bayer, Novartis, Sanofi, and Philips. Delivered transformative results by aligning complex programs with strategic business goals.
- Global Program Management: Established and managed global delivery models for large, complex projects, excelling in scope management, resource optimization, time and cost management, and project governance. Championed operational excellence with transparent metrics, reporting, and stakeholder communication, achieving a 98% on-time delivery rate across multiple complex programs.
- Strategic Business Consulting: Directed strategic initiatives across domains such as Digital Health, R&D, Clinical Operations, Quality Assurance, Regulatory Affairs, and Medical Affairs, ensuring alignment with client objectives. Drove value-driven outcomes by managing cross-functional teams and consistently meeting key milestones.
- Regulatory Consulting: Led large-scale consulting engagements and business operations for Pharmaceuticals- Regulatory Submission Publishing, Labeling Content Management, and Medical Devices- Regulatory Affairs, Quality Assurance, and Post Market Surveillance.
- Digital Health Portfolio Management: Led a portfolio of 10+ digital health projects encompassing HealthTech, Pharma, and MedTech sectors, driving innovation in E-Clinical Systems, Population Health, Remote Patient Monitoring, Digital Therapeutics, Connected Devices, and SaMD. Developed use cases that contributed to a 20% increase in adoption rates across digital health platforms by addressing critical user pain points and improving patient engagement.
- R&D Digital Transformation: Steered digital projects leveraging AI/ML, data & analytics, automation, cloud, and digital engineering capabilities to deliver R&D projects such as pre-clinical data management (CDISC), clinical data ecosystem, omics and imaging, accelerated clinical protocol development, clinical trial reproducibility, Trial Master File (TMF) automation, patient recruitment, labeling system implementation, regulatory intelligence, e-Labeling/ePI, computer system validation, etc.
- Process Improvement & Automation: Led the process improvement initiatives by collaborating with IT experts in AI/GenAI, Digital Engineering, Data & Analytics, IoT, and Automation. Enhanced operational efficiency and achieved a 25% increase in solution impact and client retention through strategic alignment with business objectives.
- Agile Product Management (SAFe): Implemented agile processes across 5+ product teams, leading to a 25% improvement in sprint velocity and faster time-to-market for key features. Developed and maintained product backlogs, prioritized features, and facilitated PI planning, resulting in 80% alignment with customer priorities during releases.
- Stakeholder Engagement: Built strong relationships with 50+ executive sponsors, business leaders, and IT stakeholders, resulting in a 95% stakeholder satisfaction score in program feedback surveys. Collaborated with cross-functional teams, vendors, and partners to drive service delivery across programs, improving operational efficiency by 20%.
- Delivery Excellence: Established and tracked KPIs, SLAs, and performance dashboards, leading to a 20% improvement in team performance metrics. Improved accountability and operational performance by introducing automated tracking systems that enhanced reporting accuracy by 30%.
- CRO Service Delivery: Successfully delivered client projects in EDC Study Setup, Clinical Data Management, Biostatistics & SAS Programming, Regulatory Affairs, and Medical Affairs.
- E-Clinical Solution Delivery: Led the lifecycle of E-Clinical solutions (EDC, IRT, ePRO, eTMF systems), from conceptualization to agile development, product and service delivery. Delivered innovative, client-focused solutions aligned with industry standards, achieving 80% on-time delivery and ensuring seamless system setups, validation, and client audits, exceeding client expectations.
- Business Analysis: Conducted detailed requirement analysis and created epics, features, and user stories, contributing to a 30% reduction in rework during development cycles. Provided product demos and user training to 100+ end users, achieving an average 4.7/5 user satisfaction score in training evaluations.
- Digital Product Strategy: Led product conceptualization and innovation, conducting feasibility and gap analysis that identified key market opportunities and prioritized high-impact features. Defined product roadmaps and business models, leading to the launch of new SaaS offerings with enhanced usability and regulatory compliance. Performed cost-benefit and pricing strategy analyses, achieving a 20% margin improvement across the product portfolio.
- Digital Product Delivery: Implemented Agile Scrum methodologies, managing the product lifecycle from inception to release, resulting in a 25% reduction in development cycles. Orchestrated end-to-end product verification, validation, and new product launches, delivering solutions that met 100% compliance with regulatory standards. Provided end-user training for 200+ stakeholders, achieving an average training satisfaction score of 4.8/5.
Domain Areas
- Digital Health/ DTx/ SaMD
- Pre-clinical and Clinical R&D
- Quality & Regulatory Affairs
- Medical Affairs
- Labeling & Packaging
- PMS & Pharmacovigilance
- AI, Data & Analytics
- Intelligent Automation
- Digital Engineering
- System Implementation
- Cloud & Cybersecurity
- Enterprise Solutions
Top Expertise & Skills
Program & Project Management
98%
Digital Product Management
95%
Advisory and Consulting
92%
Service Delivery
95%