About Me As a Clinical Systems & Technology Expert with 10+ years of cross-functional experience, I specialize in bridging the gap between life sciences operations and digital platforms. With a foundation in Biotechnology and a proven track record across CROs, pharma, and MedTech, I bring a deep understanding of clinical research combined with strong product, validation, and system implementation expertise. 🔹 Techno-Functional Strategist – Aligning clinical workflows with scalable digital solutions 🔹 CSV Specialist – Delivering audit-ready systems that meet stringent regulatory expectations 🔹 Mentor & Capability Builder – Training teams and mentoring 1000+ students across India since 2015 🔹 Social Contributor – Awarded Rare Star Award – 2025 for rare disease community leadership My Domain Expertise 🔹Product Management & Platform Ownership: Hands-on experience in implementing and managing enterprise-level clinical platforms including Veeva Vault (eTMF, CTMS, RIM), ArisG (LifeSphere Safety), Legacy CTMS, and eSource Platforms (ClinSpark). 🔹Computer System Validation (CSV): Extensive knowledge of GxP, 21 CFR Part 11, Annex 11, with validation lifecycle leadership (IQ/OQ/PQ), defect management, traceability, and compliance documentation. 🔹Customer-Facing SME: I serve as a subject matter expert for connected medical device platforms, conducting platform onboarding, client training bootcamps, SSO support, access provisioning, configuration of devices, study templates, and triage of escalations via JIRA & Service Desk tools. 🔹Clinical Trial Efficiency: Skilled in trial process optimization, stakeholder collaboration, and improving eTMF health through compliant document management and audit-readiness. 🔹 Value I Deliver I bring a solution-driven mindset backed by regulatory know-how and technology implementation experience to ensure that clinical systems not only comply but perform, scale, and enable smarter trials. My approach focuses on aligning business goals with platform capabilities to enhance operational agility, data integrity, and trial success. 🔹 Beyond Work An active mentor since 2015, I’ve supported 1000+ students across India to become industry-ready through resume optimization, LinkedIn training, and career mentorship. I’ve also led rare disease awareness programs, winning the Rare Star Award (2025) for my contributions. Let’s connect to collaborate on transforming clinical operations through intelligent systems and purposeful innovation. Email me to connect: chitranjan.healthtech@gmail.com Thanks for checking out my profile.