Suyash Nigam

Senior Product Owner at NUMEN
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Contact Information
us****@****om
(386) 825-5501
Location
Groton, Connecticut, United States, US
Languages
  • English Full professional proficiency
  • Hindi Native or bilingual proficiency

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5.0

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Sachin Karnik

Suyash is an excellent IT project manager and business analyst. He is very thorough and detail oriented in his work. He is able to work independently with limited guidance with both business and technical stakeholders. He managed complex projects such the delivery of Bring Your Own Devices for the collection of electronic Patient Reported Outcomes for a large global vaccines privotal phase 3 clinical trial program supporting the delivery of BYOD, tracking of the increase in patient engagement, and ROI. Suyash contributed to running a non-interventional clinical trial that proved the limited to no impact of scrolling due to variations in screen sizes when patient's respond to ePRO on BYOD devices. In addition, to his work in support of BYOD, he lead several implementations of sensors and wearables to support daily monitoring and tracking data for rare disease, and inflammation and immunology studies. I would highly recommend Suyash as a senior project manager or business analyst, he has a wealth of experience supporting the deployment of mobile based innovations in clinical trials, GxP computer system validation, and is an excellent communicator with both business and technical stakeholders.

Chris Dell

During my time at Pfizer I have enjoyed working with Suyash and appreciate his dedication and follow through on the many projects he manages. Suyash has been the "point" person for managing several aspects of qualifying ePRO vendors, and verifying they have gone through all the proper certifications, security checks, etc. He interacts with the vendors very well and is always diligent and thorough in his interactions.

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Credentials

  • Introduction to Generative AI
    Google Cloud Skills Boost
    Jul, 2023
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    Apr, 2022
    - Nov, 2024
  • Data Management for Clinical Research
    Vanderbilt University
    Oct, 2021
    - Nov, 2024
  • AWS Certified Cloud Practitioner
    Amazon Web Services (AWS)
    May, 2021
    - Nov, 2024
  • Infosys Global Agile certification
    Infosys Ltd
    Feb, 2021
    - Nov, 2024
  • Introduction to Web APIs
    LinkedIn
    Jun, 2020
    - Nov, 2024
  • Learning Cloud Computing: Core Concepts
    LinkedIn
    Jun, 2020
    - Nov, 2024
  • GDPR Compliance: Essential Training
    LinkedIn
    May, 2020
    - Nov, 2024
  • RPA, AI, and Cognitive Tech for Leaders
    LinkedIn
    May, 2020
    - Nov, 2024
  • Transitioning from Waterfall to Agile Project Management
    LinkedIn
    May, 2020
    - Nov, 2024
  • Machine Learning
    Massachusetts Institute of Technology
    Aug, 2019
    - Nov, 2024
  • Pega CSA 7.2
    Pegasystems
    Sep, 2018
    - Nov, 2024
  • Pega CPBA 7.2
    Pegasystems
    Jan, 2018
    - Nov, 2024
  • Google Analytics for beginners
    Google
    Apr, 2017
    - Nov, 2024
  • ITIL 2011 Foundation
    APMG International
    May, 2014
    - Nov, 2024
  • Advanced Open Water Diver
    PADI
    Feb, 2010
    - Nov, 2024
  • Open Water Diver
    PADI
    Mar, 2006
    - Nov, 2024

Experience

    • Brazil
    • IT Services and IT Consulting
    • 400 - 500 Employee
    • Senior Product Owner
      • Jun 2023 - Present

      Specialized program management and process definition in the Life sciences CAR-T commercial and clinical supply chain Specialized program management and process definition in the Life sciences CAR-T commercial and clinical supply chain

    • Business Consulting and Services
    • 700 & Above Employee
    • Manager, Life Sciences Consulting
      • Dec 2021 - Jun 2023

      Responsible for planning, managing and delivering complex digital transformation solutions for multiple Life science clients across R&D Clinical and Cell & Gene therapy. Provide expertise in the area of clinical trial operations and data management, with an advanced knowledge and expertise on Decentralized trials. Exploring and applying advance data analysis for improving patient recruitment and DEI enablement in Clinical Trials. Responsible for planning, managing and delivering complex digital transformation solutions for multiple Life science clients across R&D Clinical and Cell & Gene therapy. Provide expertise in the area of clinical trial operations and data management, with an advanced knowledge and expertise on Decentralized trials. Exploring and applying advance data analysis for improving patient recruitment and DEI enablement in Clinical Trials.

    • Canada
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Clinical Trial SME - Life Sciences Consulting
      • Aug 2021 - Dec 2021

      - Subject Matter Expert (SME) within the area of clinical operations for the Life Sciences Industry Practice team - Clinical operations and business analysis expertise for the development of a large pharmaceutical global regulatory intelligence platform - Supported Life Sciences Industry Practice team in identifying new potential business opportunities and the creation of solution responses - Subject Matter Expert (SME) within the area of clinical operations for the Life Sciences Industry Practice team - Clinical operations and business analysis expertise for the development of a large pharmaceutical global regulatory intelligence platform - Supported Life Sciences Industry Practice team in identifying new potential business opportunities and the creation of solution responses

    • India
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Senior Consultant - Life Sciences Consulting
      • Jul 2016 - Aug 2021

      Associated in different Project Manager / Business Analyst roles involving Clinical Trial Operations and Data, and Decentralized Trial Process. Below are the responsibilities that I covered at Infosys:  As project manager, I was responsible for leading greenfield solution implementations using various technology platforms.  This required close working with business and technological teams at client and company to ensure accurate process mapping to meet future industry and regulatory… Show more Associated in different Project Manager / Business Analyst roles involving Clinical Trial Operations and Data, and Decentralized Trial Process. Below are the responsibilities that I covered at Infosys:  As project manager, I was responsible for leading greenfield solution implementations using various technology platforms.  This required close working with business and technological teams at client and company to ensure accurate process mapping to meet future industry and regulatory needs.  Ensure industry best practices are followed i.e ITIL, Agile and waterfall SDLC. Bring in best practices from Infosys Business Analysis guidance.  Involved Coordinate and Prepare responses for innovative digital transformation proposals in R&D clinical and Cell & gene therapy.  Contributing to whitepapers and technology showcases in the Life sciences industry. Provide training to junior resources to help them achieve their career goals.

    • Consultant - Life Sciences Consulting
      • Oct 2014 - Jun 2016

      - PEGA Business Architect for greenfield development of Quality Management System as part of Transcelerate compliance at Pfizer. Used the Pega DCO for managing requirements and following Pfizer SDLC (Software Development Life Cycle) for process and document compliance. - Lead Business Analyst at Pfizer for .net development of Customer Engagement Program web application. Ensuring the complete SDLC process is followed, including creation of required compliance documents. - SAP Quality… Show more - PEGA Business Architect for greenfield development of Quality Management System as part of Transcelerate compliance at Pfizer. Used the Pega DCO for managing requirements and following Pfizer SDLC (Software Development Life Cycle) for process and document compliance. - Lead Business Analyst at Pfizer for .net development of Customer Engagement Program web application. Ensuring the complete SDLC process is followed, including creation of required compliance documents. - SAP Quality Consultant for AstraZeneca in the area of Change Management.

    • Senior Associate Consultant - Life Sciences Consulting
      • Oct 2011 - Sep 2014

      - Lead for SAP Quality Compliance at AstraZeneca.

    • Associate Consultant
      • Aug 2010 - Sep 2011

    • India
    • Investment Management
    • 700 & Above Employee
    • Manager (Sales & Business Development)
      • May 2009 - Aug 2010

    • United States
    • Telecommunications
    • 500 - 600 Employee
    • Summer Intern
      • Apr 2008 - Jun 2008

      Scaling the opportunity in the Enterprise Segment and Channel Strategies to be adopted for wireless headset products. Recommended for best Summer project presentation. Scaling the opportunity in the Enterprise Segment and Channel Strategies to be adopted for wireless headset products. Recommended for best Summer project presentation.

    • Research
    • 300 - 400 Employee
    • Project Assistant
      • Apr 2006 - Mar 2007

      - Responsible for overseeing the Electrical refurbishment of the Institute building. - Responsible for development of energy controls for underwater Autonomous Vertical Profiler (AVP). - Involved in coordinating with Vendors for designing and supplying Solar Panels to meet the vehicles energy requirement - Responsible for overseeing the Electrical refurbishment of the Institute building. - Responsible for development of energy controls for underwater Autonomous Vertical Profiler (AVP). - Involved in coordinating with Vendors for designing and supplying Solar Panels to meet the vehicles energy requirement

Education

  • Massachusetts Institute of Technology
    Online Program, Machine Learning
    2019 - 2019
  • Goa Institute of Management
    PGDM, Marketing and Finance
    2007 - 2009
  • Govt. of Goa College of Engineering, Goa, Farmagudi, Ponda
    B.E, Electrical and Electronics Engineering
    2001 - 2005
  • Sharada Mandir School
    1987 - 1999

Community

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