Shashi Bhushan

Experience

• 

  Natinal center for natural resources, Raipur

  Oct 2013 - May 2016

  Research fellow

  In order to have a molecule ready to pharmacuetical companies, as a team we were performing the survey for autoimmune disorders and to identify the herb used for treatment of disorders. Post that extraction and purification of the compound that are having key responsibility to cure the disorder

• 

  Accenture

  May 2016 - Mar 2020

  Clinical Document Specialist

  (A) Regulatory submission-Keep trials prepared for the successful regulatory submissions by making sure country are receiving all documents required for submission within agreed timeline(B) Audit and Inspection readiness- responsible to keep the status of TMF updated at any phase of trial according to SOPs and ICH GCP including end trend maintenance (C) Clinical Study Report- to Create and populate the high level of information in important part of clinical study report including content review of site level documents to have accurate details in report well within the timelines(D) End of trial- make sure all the information and Documents are made available to officially close the trial(E) Financial disclosure module- Preparation of FD module having high level information about financial information of study personnel for regulatory submission. Show less

• 

  Accenture in India

  Mar 2018 - Dec 2024

  Responsibilities included but not limited to manage the group of clinical document specialist responsible for supporting clinical trials getting conducted globally.Provide technical support and guidance to CDS group to following activities:>Management and maintenance of TMF at study level>compiling dossier checklist and availability confirmation for HA submission,>Providing support for selected CSR for all trialsAdditional line management activities:- Performance appraisal - Resource mapping and allocation - Objective setting and management - Creation of performance metrics - Creating and maintaining group wise info point of achievements- Identifying source of automation for different stakeholder which will enable them to save cost as well as time. Show less

  • Deputy General Manager

    Sept 2022 - Dec 2024

  • Assistant Manager

    Nov 2021 - Sept 2022

  • Team Lead

    Mar 2018 - Nov 2021
• 

  Thermo Fisher Scientific India

  Dec 2024 - now

  Manager Clinical Ops Delivery| Line Management