Experience

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  Csir institute of mineral and material technology bhubaneswar

  Jan 2016 - Jul 2016

  Research trainee
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  Icmr-regional medical research center bhubaneswar

  Jun 2017 - Jul 2019

  Clinical research associate

  site monitoring, Site selection, Training of site staff, Site feasibility, Query resolution

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  Croissance clinical research

  Aug 2019 - Aug 2021

  Clinical research associate

  Clinical research associate, Site selection, Site feasibility,EC submission, Onsite monitoring, Remote monitoring, Rave EDC, Acceliant EDC, Report preparation, Training of site staff

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  Novo nordisk

  Sept 2021 - Sept 2022

  Clinical research associate-ii
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  Eli lilly and company

  Sept 2022 - now

  Project manager clinical research

  •Provide efficient updates on trial progress to the Clinical Research Head, with respect to vendor selection, project plans, trial budget and timeline management, quality standards, and risk mitigation.•Lead sponsor study start up process, including but not limited to the conduct of the Trial Kick-off meeting, the set-up of the trial master file (TMF), site selection, and finalization of site and vendor Clinical Trial Agreements and budgets.•Ensure effective project plans are in place and operational for each trial and work with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.•Monitor the quality of vendor deliverables, address quality issues with the appropriate team member, and identify opportunities to improve training, execution, and quality control across the clinical team. Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner.•Assist and provide training to all team members.•Analyzed all project development plans and ensure computability into project implementation and monitor all material labelling for clinical trials and ensure compliance with the project timeline.•Coordinate with various team members and assist to select appropriate vendors.•Prepare various timelines and budgets for all projects and ensure compliance with all reporting standards and timeframes and analyze all medical requirements for projects.•Monitor all external services in contracts in coordination with vendor managers and escalate issues to management for effective resolution Show less