Rohit Kulkarni

Experience

• 

  Cognizant Technology Solutions

  May 2006 - May 2012

  1. Managed 3 project teams for data management of clinical trials in area of Cardiac disease management. 2. Study and Analyze Clinical Protocol to understand the eCRF system requirements. 3. Define Data Capture Standards for EDC (Oracle Clinical) and develop specifications for eCRF build, Edit checks and integration of EDC systems with other systems like CTMS.4. Liaise and coordinate activities with larger project teams members like Data Managers, eCRF developers, testers to ensure timely system Go-Live.5. Maintain and provide project timelines and effectively communicate project status reports to clinical trial leaders and program managers.6. Responsible for communication of risk & mitigation actions for all data and technical related deliverables Show less 1. Project Management for setup and validation of Clinical ePRO / IWRS systems for clinical studies2. Relationship Management with Vendors in space Data Acquisition and Reporting.3. People Management - Leading / Managing the TPC team functioning for multi-national customer locations.4. Setup of clinical systems like RAVE/ePRO/IWRS by building specifications for eCRF, Edit checks, etc.5. Validation of EDC systems - Building Validation / Test Plans, Test Scripts, Validation Reports.6. Change control management of IWRS/ePRO clinical systems.7. Owning third party processes and building relevant 3rd party standard working instructions. Show less

  • Clinical Data Management Leader

    Feb 2011 - May 2012

  • Global Third Party Coordinator Lead

    May 2010 - Apr 2011

  • Third Party Coordinator - Sweden

    May 2008 - Apr 2010

  • Advanced SAS Programmer

    May 2006 - Apr 2008
• 

  Medtronic

  May 2012 - now

  1. Encourage Innovation in creating efficiencies in Evidence Generation space. Provide leadership in expanding promising ideas to being Innovative products. Create strong Business Cases for securing funding ('Mind to Market') to high-end analytical products.2. Manage portfolio of Post Market surveillance projects, from a Data Solutions perspective.3. Manage a truly global team (across Americas, Europe and Asia) of 20+ data analysts supporting global evidence needs.4. Develop strategic outreach initiatives to drive business growth. Regularly contribute and participate in conferences to highlight innovations and achievements, and thereby increase networking and visibility to core functional capabilities.5. Accountable for creating competitive Financial forecasts for supporting Clinical Research Programs. Proactively manage Financial Variance and collaborate closely with sponsors.6. Lead and participate in high-visibility organizational initiatives, to serve the best interest of clinical research. Show less 1. Project Management of Clinical Operations2. Project manage data management of clinical trials in area of Diabetes, Neuromodulation & Cardiac Research Disease Management. 3. Analyze Clinical Protocol to understand the eCRF system requirements. 4. Define Data Capture Standards for EDC (Oracle Clinical, Outcome Logix) and develop specifications for eCRF build, edit checks and integration of EDC systems with other systems like CTMS as well as study management reports.5. Liaise and coordinate activities with extended project teams members like Data Managers, eCRF developers, testers as well as contracted vendors to ensure timely system Go-Live.6. Maintain and provide project timelines and effectively communicate project status reports to clinical trial leaders and program managers.7. Responsible for risk management for all data and technical related deliverables.8. Furnish optimal data management cost proposals for upcoming projects in multiple business units. Show less

  • Manager - Data Solutions

    Nov 2016 - now

  • Program Manager - Statistical Programming

    Jul 2015 - Oct 2016

  • Principal Clinical Data Specialist & Project Manager (Clinical Operations)

    Feb 2015 - Jun 2015

  • Clinical Data Management Leader

    May 2012 - Jan 2015
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  Sport N Socialize

  Sept 2020 - now

  Founder

  - Sports Events Organization- Sports Consultancy & IT Solutions- Sports Marketing- Brand value creation- Sports Talent Grooming and Scouting (currently focused on Badminton)- Player Management and Sponsorship