Omkesh Gharge

About Omkesh Gharge

Omkesh Gharge | Clinical Process Coordinator | Global Clinical Trials Mpharm Pharmacologist | Clinical Process Coordinator with CTMS Experience | AI Enthusiast | Working on Global Clinical Trials | 1 Year of Experience Welcome to my LinkedIn profile! I am Omkesh Gharge, an accomplished Mpharm Pharmacologist with a passion for contributing to the advancement of global clinical trials. Currently, I am an integral part of the esteemed FSP team, where I play a crucial role in supporting and streamlining clinical operations worldwide. Education: I hold a Master\'s degree (Mpharm) in Pharmacology, which has provided me with a solid foundation in understanding drug mechanisms, pharmacokinetics, and drug development processes. Experience: With a cumulative one year of experience in the pharmaceutical and healthcare industry, I have gained valuable insights into the dynamic world of clinical research. My expertise lies in efficiently handling trial administrative tasks and providing unwavering support to global clinical teams. AI Enthusiast: I am passionate about harnessing the power of Artificial Intelligence (AI) in the healthcare and life sciences domains. CTMS Proficiency: I possess hands-on experience with Clinical Trial Management Systems (CTMS), which enables me to effectively manage trial data, streamline processes, and optimize clinical trial workflows for improved efficiency. Excel Skills: Additionally, I am proficient in Microsoft Excel, utilizing its powerful features to analyze data, create reports, and support data-driven decision-making within the clinical research environment. Global Clinical Trials: My current focus revolves around driving the success of global clinical trials. I thrive on the challenges that come with managing international projects and ensuring their seamless execution. Previous Role: Prior to my current position, I served as a Clinical Research Coordinator for six months. This role allowed me to refine my skills, gain hands-on experience, and develop a deep understanding of the intricacies involved in the clinical research process. Passion and Motivation: My enthusiasm for improving patient outcomes and contributing to groundbreaking medical discoveries fuels my commitment to excellence in every aspect of my work.

Experience

1. Senior Process Associate

   Tata Consultancy Services

   Jun 2025 — Present · Thane, IN

   Supporting the end-to-end operational lifecycle of global clinical trials by ensuring high-quality data management and regulatory compliance. Expertly navigating the clinical technology landscape to maintain inspection-readiness and streamline site-to-sponsor communication.\"​Key Responsibilities & Tech Stack:​eTMF & Document Lifecycle: Drive the completeness, accuracy, and timeliness of the Electronic Trial Master File (eTMF). Experienced in document classification, metadata tagging, and quality control (QC) in alignment with the DIA TMF Reference Model.​Clinical Vault Management: Utilize Veeva Vault Clinical (eTMF & CTMS) to manage essential documents, track study milestones, and ensure seamless collaboration across global project teams.​IXRS & Inventory Oversight: Monitor patient randomization and clinical supply chain workflows using Interactive eXperience Response Systems (IXRS/IRT) to ensure drug accountability and site-level compliance.​System Administration: Manage user access and site-level configurations across diverse Vendor Systems, including EDC (Electronic Data Capture) and safety portals.​Inspection Readiness: Conduct regular TMF audits and gap analyses to ensure \"audit-ready\" status for regulatory inspections (FDA, EMA, MHRA).​Stakeholder Liaison: Act as the primary technical point of contact for investigative sites and vendors, resolving system-related queries and facilitating document exchange.

Education

• SSR Institute of Engineering & Technology

  Bachelor of Pharmacy - BPharm

• M.G.Vidyamandirs Arts & Commerce College, Surgana, Dist. Nashik 422211

  Mpharmacy, Pharmacology

• Bharati Vidyapeeth

  Master of Business Administration - MBA, Project Management

• Savitribai Phule Pune University

  Masters of pharmacy , Pharmacology