Saurabh Mhatre

Saurabh Mhatre Email and Phone Number

Global Clinical Trial Manager (Centralized Monitoring Manager) @ IQVIA
Mumbai, MH, IN
Saurabh Mhatre's Location
Mumbai, Maharashtra, India, India
About Saurabh Mhatre

Clinical research isn’t just my career—it’s my passion. With over 14 years of hands-on experience managing global clinical trials, I’ve developed a deep expertise in risk-based monitoring (RBM), decentralized clinical trials (DCT), and clinical operations process optimization. Whether it’s implementing innovative solutions like eConsent or enhancing training governance to prepare teams for success, I thrive on delivering impactful results that improve efficiency and compliance. 🚀As a Clinical Trial Manager, I’ve led diverse cross-functional teams to ensure seamless study delivery, from protocol development to closure. My expertise extends to optimizing Key Risk Indicators (KRIs), monitoring data quality, and developing risk mitigation strategies that ensure patient safety and regulatory adherence. I also take pride in driving operational excellence, spearheading centralized monitoring system enhancements, and aligning processes to global quality standards.Collaboration and knowledge-sharing fuel my professional approach. From conducting in-house ICH-GCP training to conducting RBM workshops for esteemed platforms like the Indian Society for Clinical Research (ISCR), I enjoy empowering others to excel in clinical research. My ability to connect teams, streamline operations, and solve complex challenges has consistently led to successful outcomes. 🌍I’m passionate about advancing clinical trial methodologies, and my expertise has positioned me as a process expert in areas like decentralized trial strategies and centralized monitoring. Whether it’s through innovative technology adoption, optimizing clinical trial agreements, or ensuring eTMF audit readiness, I’m committed to enhancing efficiencies in clinical trial management.📈 Always eager to grow, learn, and contribute, I’m currently seeking opportunities to leverage my leadership skills in clinical project management and quality improvement. Let’s connect if you’re interested in collaborating or exchanging ideas in the ever-evolving field of clinical operations!✨ What’s one innovation or strategy that’s helped you overcome a major challenge in clinical research? Let’s start a conversation!

Saurabh Mhatre's Current Company Details
IQVIA

Iqvia

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Global Clinical Trial Manager (Centralized Monitoring Manager)
Mumbai, MH, IN
Saurabh Mhatre Work Experience Details
  • Iqvia
    Global Clinical Trial Manager (Centralized Monitoring Manager)
    Iqvia
    Mumbai, Mh, In
  • Iqvia
    Global Clinical Trial Manager (Centralized Monitoring Manager)
    Iqvia May 2022 - Present
    • Led global clinical trials focusing on Risk-Based Monitoring (RBM) and centralized monitoring systems, optimizing study timelines and compliance• Developed and approved study-specific Monitoring Plans, Risk Assessment Plans, and Protocol Deviation Management Plans• Managed cross-functional teams, including Clinical Research Associates (CRAs), Data Managers, and Central Monitors, ensuring project delivery within budget and timelines• Conducted risk analysis to identify site performance issues and implement mitigation strategies• Functioned as a Subject Matter Expert (SME) for eConsent processes and decentralized trial methodologies
  • Tata Consultancy Services
    Process Expert - Clinical Operations (Assistant Manager)
    Tata Consultancy Services Aug 2020 - Apr 2022
    Mumbai, Maharashtra, India
    • Implemented decentralized clinical trials (DCT) strategies to improve patient recruitment and engagement• Developed Key Risk Indicators (KRIs), Key Performance Indicators (KPIs), and Quality Tolerance Limits (QTLs) for RBM• Led the rollout of monitoring dashboards and conducted training workshops for cross-functional teams on study-specific deliverables• Participated in RFI, RFP, and bid defence presentations to support business development efforts
  • Tata Consultancy Services
    Subject Matter Expert - Clinical Operations (Business Process Lead)
    Tata Consultancy Services Aug 2018 - Jul 2020
    Mumbai, Maharashtra, India
    • Designed centralized monitoring models and conducted feasibility assessments to optimize trial operations.• Managed RBM setup deliverables, ensuring alignment with regulatory requirements and client expectations.• Conducted workshops on RBM for the Indian Society for Clinical Research (ISCR) preconference
  • Tata Consultancy Services
    Team Lead - Rbm (Business Process Lead)
    Tata Consultancy Services Oct 2017 - Jul 2018
    Mumbai, Maharashtra, India
    • Developed comprehensive Risk-Based Monitoring plans and led central monitoring teams to ensure adherence to clinical protocols and regulations• Enhanced monitoring dashboard functionalities, facilitating real-time data analysis and risk mitigation strategies across multiple trials
  • Boehringer Ingelheim
    Clinical Research Associate
    Boehringer Ingelheim May 2016 - Sep 2017
    Mumbai, Maharashtra, India
    • Conducted onsite and remote monitoring visits, ensuring compliance with study requirements, company SOPs, and Good Clinical Practice (GCP)• Assessed site capabilities and performance, implementing corrective actions to maximize efficiency and data quality
  • Sanofi
    Clinical Research Associate
    Sanofi Jul 2014 - Apr 2016
    Mumbai, Maharashtra, India
    Functioning as CRA on global, local clinical trials and registry studies, involved in site selection, monitoring, closeout, QC visits.
  • Sanofi
    Senior Clinical Project Associate
    Sanofi Apr 2014 - Jul 2014
    Mumbai, Maharashtra, India
    Functioning as in-house CRA for conduct of global, local clinical trials and registry studies.Mentoring Clinical Project Associates.
  • Sanofi
    Clinical Project Assistant
    Sanofi Jan 2012 - Apr 2014
    Mumbai, Maharashtra, India
    Functioning as in-house CRA for conduct of global, local clinical trials and registry studies.Mentoring Clinical Project Associates.
  • Quintiles
    Intern Site Identification And Feasibility
    Quintiles Oct 2010 - Apr 2011
    Mumbai, Maharashtra, India
    Functioning as Site Identification and Feasibility executive to identify, evaluate new sites and maintain potential sites list for multiple therapeutic areas.Liaising with potential sites upon receipt of Clinical Trial RFP for study specific evaluation and site selection process.

Saurabh Mhatre Skills

Java Javascript Cascading Style Sheets Management Programming Android React Reactnative Node Chef Framework Puppet Docker Tvml Devops Node.js React.js Nginx

Saurabh Mhatre Education Details

Frequently Asked Questions about Saurabh Mhatre

What company does Saurabh Mhatre work for?

Saurabh Mhatre works for Iqvia

What is Saurabh Mhatre's role at the current company?

Saurabh Mhatre's current role is Global Clinical Trial Manager (Centralized Monitoring Manager).

What schools did Saurabh Mhatre attend?

Saurabh Mhatre attended Cranfield University, Institute Of Clinical Research Professionals (India), University Of Mumbai.

What are some of Saurabh Mhatre's interests?

Saurabh Mhatre has interest in Social Services, Education, Environment, Science And Technology, Human Rights, Animal Welfare, Arts And Culture, Health.

What skills is Saurabh Mhatre known for?

Saurabh Mhatre has skills like Java, Javascript, Cascading Style Sheets, Management, Programming, Android, React, Reactnative, Node, Chef Framework, Puppet, Docker.

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