Experience

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  Pharma professional services

  Mar 2015 - Mar 2017

  • Clinical Research Coordinator • Managing Clinical Department, Liaising Principal Investigators & Sponsors (Pharma Industry). • Organize the Trial conduct from startup till the end according to E6 ICH-GCP guidelines of Clinical Trial Conduct. • Manage the regulatory requirements for Phase II, III & IV Clinical Trials & Bio-equivalence Trials. • Devising Study Protocols, CRFs, Inform Consents & Clinical Study Reports. • Registration of Clinical Trials on FDA and WHO registry of Clinical Trials. • Publication of clinical studies in peer reviewed scientific journals. • Scientific Data Monitor, Drug Information system@ druginfosys.com • Monitoring of scientific data on online portal of http://druginfosys.com• Physiology Based Pharmacokinetic Modelling Scientist. Published Research Work in International impact factor journals, various research projects are in progress: • Collaborative Research Projects with Dr. Iftekhar Mehmood, Division of Hematology Clinical Review Branch, OBRR, CBER, FDA, Silver Spring, MD. Show less

  • Clinical Research Coordinator

    Feb 2016 - Mar 2017

  • Clinical Research Associate

    Mar 2015 - Feb 2016
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  Hilton pharma limited

  Apr 2017 - Feb 2020

  • KOL development & engagement in the specialized areas of Hilton Pharma.• Developing & Disseminating Medical Strategies among internal stakeholders and KOLs• Training of External Stakeholders/ KOLs, Team training, Protocol training, SPSS workshops.• Strategical support to commercial team ensuring ethical activities.• Marking Scientific Corporate image of Hilton Pharma, through CME's Data Roll Outs.•Initiate, Monitor, Regulate & Analyze Clinical Research activities of Hilton Pharma.•Training of & Liaising with Investigators, Study Coordinators, and Hilton representatives.• Ensure ICH-GCP in the conduct of the trials.• Devising Clinical study related essentials.• Cross-functional support to Regulatory Division.• Cross-functional support to Business Development Project. Show less

  • Pre-Clinical Development Project (Short Term)

    Jan 2019 - Feb 2020

  • Medical Affiars & Clinical Research Professional

    Apr 2017 - Feb 2020
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  Aspin pharma pvt. ltd. (an obs group company)

  Mar 2020 - Feb 2021

  Assistant manager, medical affairs

  • Leading Clinical Research Projects of Aspin Pharma• Managing Medical Compliance activities• Managing Medical Training for internal stake holders• Advisory Boards, CMEs. FGDs• Portfolio Enhancement & Business Development Support• Digital projects for better business operations

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  Metrics research (private) limited.

  Feb 2021 - now

  • Managing complete operations of medical affairs, clinical function, pharmacovigilance.• Devising Strategic Aspects of the company and propose directives for future pursuance in the projects.• Project management for Phase I-IV clinical trials, BA/BE study projects, Pharmacovigilance, Real World Study Projects • Primary liaising point with the sponsors globally for all sort of study projects. • Leads cross-functional teams• Responsible for continuity of quality management systems• Team’s training, building, company capacity building, newer portfolios development. Show less

  • General Manager

    Feb 2024 - now

  • Director Medical Affairs & Clinical Operations

    Aug 2022 - Feb 2024

  • Manager Medical Affairs & Clinical Operations

    Feb 2021 - Aug 2022