Amitesh Thakur

About Amitesh Thakur

With 13+ years of experience in Clinical Research, I specialize in Global Study Start-Up,…

Experience

1. Manager, Clinical Operations (Global Study Startup)

   ICON plc

   Jun 2022 — Present · Mumbai, IN

   Prioritizes and effectively manages the oversight of the start-up strategy and execution by leading a team of Global Study Startup Associates for assigned studies. This includes supporting site identification, site recruitment, site selection, central and local submissions, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs), and overall site activation readiness, to ensure deliverables meet quality and regulatory requirements, project timelines, and sponsor expectations.• Ensures quality standards and applicable regulatory requirements are met in accordance with the protocol, applicable guidelines, and local regulations for IP release and site activations.• Communicates effectively with the sponsor, project manager, functional team leads, and other project team members regarding study start-up strategy and risk mitigation planning. Selects appropriate communication platforms to convey information effectively and efficiently. Leads team meetings and presents at intra-/interdepartmental and external meetings.• Identifies potential risks associated with start-up activities and deliverables, including proactive contingency and mitigation planning.• Responsible for the management of resources and resource projections to ensure project teams align with client needs, expectations, and contractual obligations.• Provides functional management support to direct reports, including professional development, performance appraisals, and employee counseling/mentoring.

Education

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  M.Pharma

  2009 — 2011

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  Bachelor of Pharmacy (B.Pharm.)

  2005 — 2009