Architakamal Mitra

About Architakamal Mitra

Architakamal is a Strategic Life Sciences Consultant with 13+ years of experience enabling digital transformation across Clinical, Safety, and Quality operations. He began his career in Clinical Operations—driving execution excellence, audit readiness, and trusted data for global studies.As his responsibilities grew, he expanded into business analysis, regulatory data governance, and system validation—enhancing compliance, data integrity, and platform performance across industry-leading solutions including Veeva Vault, TrackWise, and Oracle EDC applications.Today, he leads high-impact transformation initiatives across the Life Sciences and Pharma ecosystem. His work spans decentralized trials, AI/ML model validation, GenAI-enabled automation, and enterprise process optimization.He combines strategic thinking with hands-on delivery to convert complex requirements into scalable solutions that improve efficiency, reduce risk, and enable faster decision-making.He is recognized for aligning stakeholders, mentoring high-performing teams, and shaping Business process and technology strategy while partnering with leadership on cross-location capability expansion, go-to-market initiatives, and talent development. He partners closely with clients/leadership on strategic pursuits—advising on solution design, compliance needs, and change adoption for successful outcomes.Passionate about the future of Clinical Operations and Pharmacovigilance, he is committed to enabling better patient outcomes through next-generation data, automation, and intelligent insights.Architakamal is focused on building client trust by enabling smarter innovation that delivers real business value, and driving measurable improvements in performance and quality.

Experience

1. Manager

   EY

   Feb 2023 — Present · Kolkata, IN

   Functional SME – Medical Devices• Redefined enterprise process taxonomy across Quality, Regulatory, Clinical & Medical Affairs—benchmarking maturity against industry standards to enable scalable operating models.• Assessed post-acquisition org structure through executive and customer interviews, delivering strategic recommendations to improve integration and performance.Business Process & Data Migration Lead – Pharma• Led product-complaint data/process migration to Veeva QMS, ensuring continuity, integrity, and improved digital quality governance.• Aligned cross-functional stakeholders on transformation requirements and data-migration methodology to accelerate adoption and outcomes.Validation Lead – Pharma• Directed end-to-end validation of an AI/ML model predicting Stage-3 CKD risk via retinal scans—ensuring GxP compliance and future medical-device readiness.• Authored validation and change-control frameworks addressing AI, ML, and computer-vision complexity.Automation & GenAI Governance• Shaping automation strategy for Clinical Data Management and Analytics to enhance efficiency across the trial lifecycle.• Co-developing AI-enabled PV use cases to strengthen safety surveillance and operational performance.

Education

• Calcutta Boys' School

  Science

  1994 — 2007

• Haldia Institute of Technology

  Bachelor of Technology - BTech, Biotechnology

  2007 — 2011