Sheetal Shetty

Sheetal shetty

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  • Timeline

    Feb 2011 - Jun 2014

    Senior Business Development Executive- ReliCord, Diagnostics and IVF

    Reliance Life Sciences Pvt. Ltd.
    Bangalore, Mysore, Mangalore and Udupi
    Current Company
    Jun 2014 - now

    Document Controller

    Novo Nordisk
    Bangalore
  • About me

    Document Controller

  • Education

    • Clincal research education and mangement academy

      2009 - 2010
      Clinical research and business proficiency skills life science
    • Alvas college

      2006 - 2009
      B.sc biotechnology biotechnology, chemistry, botany
    • Viveka p u college, kota, udupi district

      2004 - 2006
      Pcmb
  • Experience

    • Reliance life sciences pvt. ltd.

      Feb 2011 - Jun 2014

      • Handling ReliCord, Diagnostics and IVF Products • Promoting IVF products and Diagnostics service to doctors of relevant specialties• Focus on quality, precision and punctual delivery of services• Conducting various scientific training and workshops with Paramedics• Increasing productivity by venturing new possibilities in Customer acquisition• Scientific Presentations on Stem Cells preservation to private & corporate Clients• Generation of business through organizing events to create awareness of stem cells to expecting parents Show less

      • Senior Business Development Executive- ReliCord, Diagnostics and IVF

        Nov 2012 - Jun 2014
      • Business Development Executive – Scientific Communication in Regenerative Medicine

        Feb 2011 - Oct 2012
    • Novo nordisk

      Jun 2014 - now

      1. Distribute safety reports (SUSARs/CIOMS/PSURs) and Investigator's Brochure (IB) to NN clinical trial sites globally through CONNECT-NN Investigator Portal2. Responsible for establishing and maintaining the document handling process according to local requirements and involvement of expanding the distribution process to other documents types3. Participate in knowledge sharing and skill building activities. To maintain good collaboration with Stakeholders4. Manages business complexity5. Creates and communicates a clear, shared vision for the future6. Maintains the distribution handbook and updates the same regularly in accordance with any changes in the affiliate areas or local requirements for distribution, in collaboration with Global Safety, CTA Management and CONNECT Team7. Prioritizes and balances time, actions, resources and initiatives to ensure accomplishment of critical results 8. Focuses on development of self and others to accelerate performance in current and future roles. Provides others with candid, timely and constructive feedback9. Sets clear and ambitious goals and holds self and others accountable for meeting standards of excellence. Show less • Operations on External Site and User Management• Maintain study versions in end-user systems for e.g. : EDC• Create and maintain users account information for external stakeholders (create / maintain) from UMT for systems e.g. : EDC, ePRO• Provide functional support to the clinical systems managed by CS&DM. The primary users should be able to get support on the use of the systems, report functionality (standard and/or adhoc) and the system supporter should be able to provide a way to a solution.• Should be knowledgeable of the other systems that are managed by CS&DM, and help in understanding the system architecture.• Is responsible for providing support and guidance to the process of transferring data between clinical systems in CS&DM• To be knowledgeable about the support organisation that provide specific support for the interfaces in the system architecture• To ensure continuous improvement of the use of the clinical systems in CS&DM• To be active in providing support for the optimal work processes supported by the clinical systems in CS&DM Show less • Ensure integrity of clinical trial databases• Accountability and tracking of documents for each batch recieved and report any descrepancies to trial data manager• Data entry of clinical data into database with accuracy and speed• Scanning and cleaning of CRFs and other documents as per project requirements• Perform Hyperlinking and Bookmarking tasks of CRFs/ eCRFs in order to make it ready for submission• Involve in archiving of trial related documents to HQ or locally as per TMF archive specification• Identify risks and inform Data Manager in a timely manner• Ensure consistency on the tasks as per the trial requirements within a clinical project by adhering to current standards and related SOPs, paper CRF modules and safety forms•To identify the stakeholders need for data and information and communicate as needed• Problems and precedents are not always clear, therefore innovative thinking and a degree of independence is expected to ensure that the data quality and timelines are not affected Show less

      • Document Controller

        Nov 2019 - now
      • Associate EDC/ePRO Operations Specialist

        Sept 2016 - Nov 2019
      • Clinical Data Associate

        Jun 2014 - Sept 2016
  • Licenses & Certifications