Abhijit Sharma

About Abhijit Sharma

A seasoned and accomplished clinical research leader with career advancements over 20 years, I present myself as a qualified professional with an extensive background in working with new and existing drugs and all stages of the clinical trial. Through my unmatched prowess, I have acquired remarkable proficiency in maintaining a successful track record in global end-to-end clinical study management, leading a team of research experts and data scientists through innovation, business expertise, and people management capabilities-SKILL-SET- Deliver technical expertise in research and pharmacovigilance in Neglected Tropical Diseases (NTDs) Proficiency in medical research for the creation of therapeutics and diagnostic tools. Coordinate the efforts of the Clinical Study Team, the global CROs, and the trial sites to ensure a successful trial. Worked with Clinical Operations, Regulatory Affairs, and other key stakeholders, and have a thorough understanding of all stages of pharmaceutical drug product development, from proof of concept to managing clinical trials to submitting an investigational new drug application to transferring technology. Educational background in Anatomy, Physiology, Public Health, Clinical Pharmacology, Pharmaceutical management & market dynamics, and Drug Development Processes. Good working knowledge of ICH-GCP, CDSCO, USFDA, and other regulatory requirements in medical research. I possess keen spirit & a far sight into the problems; I could perceive beyond what was evident. With this added strength, I was efficient in continuously procuring result-driven outcomes. With many accolades in Clinical Research operations under my wings, I am always pursuing novel ways to drive value to the organization while pruning my skills to the optimum level. Connect with me at a••••••••@gmail.com

Experience

1. Senior Project Manager and Senior Program Officer, Clinical Trials

   PATH

   Apr 2014 — Present · New Delhi, IN

   In my present capacity, I am accountable for identifying the need for research and possible impact and strategizing based on budget and duration. I also steer the clinical study team by providing direct operational input into protocol development to ensure efficient and effective delivery of trial objectives. My other job duties include the following: Formulate and execute overall clinical strategy for assigned clinical projects; lead trial management activities within assigned projects. Define the project plans (i.e, timelines, milestones and limitations for project staff). Create, execute, update, and maintain the project schedules. Organize and delegate the needed resources for project completion. Assure timely address of trial audit responses or other quality issues in conjunction with quality assurance. Direct with appropriate line functions to ensure data capture and cleaning is consistent with trial timelines; identify issues and drive the process to ensure timely resolution. Coordinate activities and deliverables of all project conduct partners and proactively identifies and manage issues. Furthermore, I handle a project overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), WHO Pre-qualification requirements, and country regulatory requirements. As Senior Program Officer, I steer the overall project of providing technical support to the Government of India, Maharashtra, and Uttar Pradesh in Malaria, Dengue, and Chikungunya control through a large-scale CSR grant project. I was responsible for managing Malaria elimination support activities: Responsible for India activities aligned with the global objectives and log frame. I also supported evidence generation, operational research model design, project management, use case identification, primary and secondary research, and dissemination.

Education

• APMG, Buckinghamshire, UK

  PMD Pro Level-2

• College

  MD, Alternative Medicine

  2004 — 2006

• University Of North Bengal

  Bachelor's degree, Pharmacology, Drug Development and Drug Administration

  1998 — 2002

• ICRI India

  Post Graduation, Drug Development, Clinical Research and Pharmacovigilance

• IIPM

  MBA, Pharmaceutical Management and Marketing

• Public Health Foundation of India

  Pharmacovigilance, research analysis and data management