Gauri Khare

Experience

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  Reliance Clinical Research Services

  Feb 2005 - Jun 2007

  Clinical Trial Supplies Management – Specialist II

  • Monitored storage conditions of the facility and coordinated with the Maintenance dept on regular maintenance of the storage facility.• Reviewed and prepared Standard Operating Procedures for the Storage facility and Storage of Investigational products• Coordinated with the IVRS system regarding the receipt, randomisation and dispatch of the supplies to the sites.• Coordinated with study team and vendor for procurement of local study drugs.• Storage and dispatch of drug material and maintenance of drug accountability for different studies.•Preparation of the Label designs as per the regulations and randomized label as per the study requirements Show less

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  Sanofi Aventis

  Jun 2007 - Jun 2008

  Investigational Product -Manager

  • Prepared local SOPs for Investigational Product (IP) / study drug management at warehouse as per Local regulations• Coordinated with global counterparts for import and logistics of the IP/CTS • Coordinated with Global for the Label Text Validation for the IP • Coordinated with Purchase department / Vendor for purchase of local study drugs• Coordinated with Regulatory Department and monitoring department for Import /Export License application and tracking.• Coordinated with the Custom Clearing agent for the Custom Clearance of the Import consignment. • Prepared Ancillary Labels for local study drugs for clinical trial use.• Reviewed storage of the study drugs and accountability of the IP/ study drugs at warehouse.• Worked with IWRS for the management of study drugs • Audit Preparedness for managament of IP Show less

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  SIRO Clinpharm Pvt. Ltd.

  Jul 2008 - Aug 2018

  Manager-Clincal Trial Supplies Management

  • Develop/ write SOPs for CTSF processes.• Coordinate with Sponsors, Project Management Teams, SIRO CTS personnel for approval of invoices for import; coordinate with customs agent for clearances, arrange for duty payments through Finance to ensure smooth importation of CTS• Draft Project Management Plan for the projects allocated and obtain approval from Line Manager• Train the Project team allocated on the requirements of the IP storage and distribution of individual project • Develop/revise the Quality Manual/Business Continuity Plan for the facility• Line Management of the direct Reports • Preparation of Training Plan and training the Team • Ensure preparedness of warehouse facility for audit.• Hosting internal/External Audits and client visits• Preparation and Implementation of the CAPA for the Audit Reports• Documentation of Complaints/Deviation and Change Control Process• Ensure accurate billing of the project is done by finance as per contract and initiate change order for extension of project/out of scope activity• Coordinate with IWRS for the receipt and distribution of the study drugs Show less

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  Sanofi

  Sept 2018 - Oct 2020

  Investigational Product Manager
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  Abbott

  Oct 2020 - Aug 2022

  Manager Clinical Supplies
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  ABBOTT HEALTHCARE LIMITED

  Jul 2022 - now

  Senior Manager Clinical Supplies Management