Assistant Manager
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SUMMARY

  • An accomplished professional with overall 8+ years of experience in Project Management
  • Demonstrated experience in Product development according to regulatory requirements - ICH, US-FDA, EMEA, WHO and DCGI guidelines
  • Adept in clinical research including all aspects of the Bioavailability and Bioequivalence (BA/BE) studies, Phase III clinical trials etc.             
  • Experience in developing plan, budget and timelines according to project specifications and ensuring projects are delivered with high quality and in specific timeline by utilizing all resources
  • Strong ability in review and finalization of Confidential Disclosure Agreements (CDA), Master Service Agreement (MSA), Contracts and Agreements
  • Proven ability in preparation of cost proposals for BE Studies, Phase I to IV Clinical trials & other customized studies and negotiating contracts with entities sponsoring clinical research
  • Dexterous in leading the regulatory compliance activities of the company and involved in making the documents, internal audits, reports, etc.
  • Deft in improving communication among different departments, delivers projects in matrixes organizations across the world
  • Proficient in working with corporate vendors and build long-term relationships with vendors/clients and enhancing business improvements
  • Successfully received “Welcome and Wanted” award in Feb, 2018 by Synchron Research Services Pvt. Ltd.
  • Skilled in MS Office, MS Project and Internet Research
  • Well-organized with excellent leadership qualities and excellent interpersonal and conflict resolution skills
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