Vinay Agrawal

About Vinay Agrawal

With over two decades of multifaceted experience spanning pharmaceutical marketing, basic laboratory research, BPO, teaching, and clinical research, I offer a unique and comprehensive perspective on driving operational excellence and cultivating transformative leadership within the clinical trials landscape.My journey in Clinical Research began as a monitor at IQVIA (erstwhile Quintiles), where I was instrumental in establishing the Functional Services business line. I\'ve since gained extensive expertise in Project Management, Vendor Management & Outsourcing, and core Operational Lead activities, working effectively with both CROs and sponsor companies. In my current role, I lead the Centralized Monitoring team at IQVIA Biotech India, having rejoined IQVIA in 2014 to play pivotal roles in setting up centralized operations, implementing new services, driving change management, and executing numerous people-centric initiatives across various centralized teams. Throughout my career, I\'ve successfully managed large teams, including those exceeding 250 employees, demonstrating a deep passion for large-scale people management and developing high-performing teams.Beyond operational leadership, I am a dedicated advocate for fostering the next generation of leaders. I actively mentor and coach aspiring and transitioning managers, providing practical guidance to navigate leadership complexities, build resilience, and enhance strategic decision-making. My leadership philosophy is rooted in empathy, driving not only individual professional growth but also sustained organizational success.Passionate about the intersection of clinical innovation and effective leadership, I am keen to contribute through speaking engagements, guest lectures for MBA programs, and strategic collaborations focused on shaping the future of clinical research and developing impactful leaders.

Experience

1. Director- Clinical Monitoring Iqvia Biotech

   IQVIA

   Jun 2022 — Present · IN

   Global Strategy & Delivery: Drive global strategies, initiatives, processes, & standards to ensure consistent, efficient, & quality delivery of high-quality clinical data for Centralized Monitoring & Site Visit Report Reviewer (SVRR) teams. RBM Strategy & Execution: Serve as a key leader in defining, delivering, & executing the Risk-Based Monitoring (RBM) implementation plan, encompassing strategy development, global training, change management & comprehensive communication plans. Data Surveillance & Risk Assessment: Collaborate closely with Central Monitors to build capabilities for assessing site-level data & information, strategically focusing resources on risks with the highest potential impact on data quality & patient safety.Organizational Design & Governance: Established formal charters for people managers & Lead Centralized Monitors, defining standardized career ladders & job profiles to support global talent mobility & secure governance approvals. Resource Utilization & Resourcing: Assess global resourcing needs & ensure business continuity by providing trained resources & driving data-backed justifications for additional headcount to meet organizational demands. Operational Growth: Evaluated existing people & processes to build new lines of business, successfully expanding the centralized monitoring remit and scaling the team. Cross-Functional Collaboration: Liaise with multiple local and global stakeholders and sponsors to ensure smooth study conduct, resolving complex conflicts and operational escalations to protect quality and delivery. Talent Acquisition & Development: Direct hiring & interviewing for centralized monitoring roles, strengthening assessment depth while providing ongoing coaching and performance management.Employee Wellness & Culture: Championed comprehensive employee wellness initiatives, integrating mental health awareness & work-life balance into a structured recognition framework to reinforce a high-performance culture.

Education

• Indira Gandhi National Open University

  MBA, Operation Management

  2008 — 2012

• G N Khalsa College

  B.Sc, Microbiology

  1998 — 2001

• University of Mumbai

  M.Sc, Applied Biology

  2001 — 2006

• GlobalNxt University

  Doctor of Philosophy - PhD, Management

• Bombay College of Pharmacy (ACE)

  PG Diploma in Clinical Research, Clinical Research

  2006 — 2007

Skills

• Drug Development
• Gcp
• Line Management
• Regulatory Affairs
• Electronic Data Capture (Edc)
• Oncology
• Protocol
• Clinical Operations
• Pharmacovigilance
• Life Sciences
• Quality Assurance
• Good Clinical Practice (Gcp)
• Edc
• Therapeutic Areas
• Regulatory Requirements
• Ctms
• Standard Operating Procedure (Sop)
• Clinical
• Project Management
• Clinical Research
• Clinical Pharmacology
• Clinical Trials
• Regulatory Submissions
• Management
• Biotechnology
• Leadership
• Ich-Gcp
• CRO Management
• Clinical Data Management
• Data Management
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• CRO
• Pharmaceutical Industry
• Sop
• Fda
• Clinical Development