Nirav A Jansari

Experience

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  Lambda Therapeutic Research

  Jun 2006 - Aug 2008

  Sr. Clinical Research Associate (Sr. CRA), Medical Writer

   Worked as a CRA and medical writer for clinical trials

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  Zydus Cadila [Zydus Research Center]

  Jun 2009 - Jan 2010

  Research Fellow

  Undertook post graduate project work in Drug Metabolism & Pharmacokinetic department (DMPK) of Zydus Research Centre; Cadila Healthcare Ltd.For completion of project thesis for award of M. Pharm.-Pharmacology degree.

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  Lambda Therapeutic Research

  Jan 2010 - Mar 2014

  • Clinical study documents like clinical trial protocols, clinical study reports, clinical CTD modules, investigators brochures, clinical trial safety reports, regulatory submissions etc by performing literature search, organizing the information.• Independent ethics committee (IEC) meeting, responding to the IEC concerns and maintaining the documents.• Handling clinical trial initiation, monitoring and closeout activities as per applicable regulations and SOPs. • Preparing and reviewing the study related essential documentation-ICF, Source Data Verification, patient screening/randomization procedures, reviewing SAE reporting requirements, Drug accountability logs, CRFs at the site to check & ensure the completeness & accuracy with compliance to protocol, GCP & regulatory requirements.• Development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents. • Communication to the sponsor or IEC (where required) regarding the clinical conduct and sending the updates periodically.• Reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures. • Direct interaction with clients for project briefings and have the proven ability of completing a project, right from briefing stage to final delivery, with minimal supervision Show less

  • Sr. Executive-Medical Affairs

    Apr 2012 - Mar 2014

  • Executive-Medical Affairs

    Jan 2010 - Mar 2012
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  Veeda Clinical Research

  Apr 2014 - Dec 2019

  Manager Clinical Operations

  Evaluating study design and trial feasibility for patient based PK and clinical endpoint studiesProvide input for the study budget by identifying critical study activities and issues Giving technical inputs in response to client's RFPs and attending techno-commercial client meetings to showcase capabilitiesResolving queries of sponsor, investigators regarding study protocols and study plan and other study documentsPreparation and review of clinical trial documents/SOPs related to Protocol, ICF, Patient Diary Card, Feasibility Questionnaire, Clinical Study Reports etc.Interact with cross-functional team(s) through early planning, start-up and conduct phase to contribute to effective and efficient delivery of the projectProvide study-specific training to Clinical Operations staff.Study Start-up Activities, Pre study qualification visits, SIV, SMV, SCV as requiredProvides input on vendor selection, KOL identification and issue resolutionAs a part of Business Development activity:Meeting the clients to explain the capabilities of Veeda as requiredPreparing and reviewing various documents necessary to showcase Veeda’s capabilities Show less

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  Novartis

  Dec 2019 - Sept 2023

  Senior Clinical Development Manager

  Clinical Development of complex products, 505 b(2) products; Planning and managing clinical trials in different therapeutic areas of respiratory, oncology etc. for Sandoz division of Novartis

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  Sandoz

  Sept 2023 - now

  Working with the dynamic and experienced team of clinical researchers and bioanalysts to contribute for making the medicines accessible to patients

  • Group Head Clinical Development

    May 2024 - now

  • Senior Clinical Development Manager

    Sept 2023 - Apr 2024