SANTHOSH M.S.

Experience

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  HEALTHWAY MEDICAL CENTRE

  Jan 2006 - Feb 2007

  Business Development Executive
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  Piramal Foundation

  Mar 2007 - Feb 2008

  Territory Business Manager
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  Lotus Labs Pvt Ltd

  Feb 2008 - Dec 2013

  Senior Executive Clinical Quality Assurance

  • Assist with the development and maintenance of audit programs (System & Facility) as part of the quality assurance program.• Deftly audit ongoing studies, systems and documents.• Ensure quality assurance compliance with regards to, Good Clinical Practice (GCP), Good lab Practices (GLP), Standard Operating Procedure’s (SOP’s) & Protocol.• Update senior management regularly on the level of compliance and compliance issues.• Maintain Master copy of Standard Operating Procedure’s (SOP’s) & handle distribution of Controlled Copies.• Check the log books as a part of System audit.• Archive study records, Protocols & raw data.• Recommend corrective actions/improvement in procedures and training requirement.• Generate audit plans and report for sponsors and management.• Handling of Investigational Product (IP). • Promote quality standards and awareness for all company staff. • Provide Good Clinical Practice (GCP) / Quality Assurance (QA) consultation for all company staff. • Keep abreast with relevant guidelines and assist with all the internal training and training of junior auditors.• Assist in the review of company Standard Operating Procedure’s (SOP’s).• Participate in Clinical data review meeting with Study personnel & Principal Investigator. • Reviewing Calibration and validation related documents and activities.• Review of Study Protocols & CRF’s.• Review clinical study reports.• Vendor Audits.• Medical Diagnostics Audit. Show less

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  Novo Nordisk

  Dec 2013 - now

  Project responsible supporting Clinical Trial Data Management for overseeing data collection, validation, and management of data generated during a clinical trial and implementation of data collection systems, ensuring data quality and integrity. Handling various stakeholders including vendors, researchers, statisticians, and regulatory authorities, ensuring that the data collected is accurate, complete, and follows regulatory standards. Support Global Development GSC in maintaining the quality management system as per Novo Nordisk requirements including Training, Records management, handling of Non-Conformity, audit preparation/followup & support during conduct of audits/inspections & compliance to Business ethics. Support GD GSC in maintaining the quality management system as per Novo Nordisk requirements & also support GD GSC in preparation and conduct of audits and inspections.

  • Senior Clinical Trial Data Manager

    Mar 2022 - now

  • Senior Quality Management System-Professional

    Oct 2017 - Mar 2022

  • Quality Management System-Professional

    Dec 2013 - Sept 2017