Shantanu Nath

Experience

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  Cranfield University

  Aug 2008 - Jun 2011

  Senior Lecturer, Exam Evaluator & Project Guide

  Senior Lecturer, Exam Evaluator & Project Guide Guided more than 150 Clinical research thesis work being a Cranfield Master's degree thesis "Project guide".• Recognized as Exam Board assessor from CRANFIELD University (U.K.) and PRIST University (India), and evaluated board papers from December, 2008 to May, 2011.• Recognition of Lecturer status (RTS) from CRANFIELD University (U.K.) in the year 2009.• Demonstrated responsibility of the Member-Secretary of ICRI Independent Ethics Committee –Ahmedabad (IIEC-A) for two years.• National Coordinator for MSc. Clinical Research curriculum by CRANFIELD University (U.K.) operated in ICRI- India.• Delivered seminar and conducted workshops in various colleges on several aspects of Pharmacology, Pharmaceutics and Clinical research areas. Show less

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  ICRI India

  Mar 2009 - Jun 2011

  Member secretary , Ethics Committee - IIEC-A

  Promoting the ethical practice of Clinical research;Providing guidance to members on ethical matters relating to Clinical research;Overseeing, monitoring, coordinating and communicating to members and the public;Considering the impact of ethical issues and guidance on training, education and continuing professional development, and to develop mechanisms for communicating relevant information into Institutions responsible for delivery in those areas;Taking steps proactively to prepare, or have prepared, ethical guidance statements, or have modified existing statements when deficiencies in the current guidance available from the Society become apparent;Developing the means and mechanisms to assist members in the consideration and resolution of ethical dilemmas;Maintaining an awareness of the ethical statements;Monitoring diversity and equality issues. Show less

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  IICR Imperial Institute of Clinical Research

  Jun 2011 - Mar 2014

  Head of the Dept. Professor in Clinical Research

  • Conducting workshops and train students on mock PV database and GPV practices. • As H.O.D. have been associated in tie up activities and consulting activities with Pharma companies, CROs, University associations and many other research Institutions.• Demonstrated as a strategy maker for smooth functioning of a research oriented institute and achieved the academic goal. • Designed & implemented the course curriculum and training calendar.

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  Tata Consultancy Services

  Apr 2014 - Apr 2020

  - Maintenance of internal compliance and lead Clinical Quality Management Audits for Safety and Regulatory Affairs.- Attend account level Governance meetings with clients and working towards process improvement.- Liaising all applicable QA entities and ensuring that all CAPAs are implemented in a timely manner.- Auditor, Internal Quality Management System, TCS life science Accounts. - Assessing and driving to improve the account health in terms of Training and Compliance framework. Show less

  • Manager, Quality Compliance for Safety and Regulatory Affairs, IQMS Auditor.

    Jan 2016 - Apr 2020

  • Internal Auditor, Training & Compliance Lead for Safety and Regulatory Affairs

    Mar 2015 - Dec 2016

  • Pharmacovigilance Process Lead

    Apr 2014 - Mar 2015
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  Bioclinica

  Apr 2020 - Jan 2022

  Lead Auditor, Quality Assurance and Regulatory Compliance

  PRIMARY RESPONSIBILITIES• Assure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines.• Lead cross-functional teams to help identify potential issues and resolve current issues.• Directly manage & coordinate internal and external compliance auditing programs at Bioclinica.• Deploy, Manage & improve quality management system and create awareness across the organization.• Ensure effective execution of regulatory readiness program for eventual regulatory audits.• Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments).• Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues.• Impart awareness session on applicable regulations (FDA, MHRA etc.).• Overseeing CAPA management & facilitate effective corrective and preventive action (CAPA) closure. Show less

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  GSK

  Jan 2022 - now

  Manager CQA CAPA Oversight - Development GQA, MedRegQ at GSK