Saurabh Mhatre Email and Phone Number
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!
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Global Clinical Trial Manager (Centralized Monitoring Manager)IqviaMumbai, Mh, In -
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 -
Process Expert - Clinical Operations (Assistant Manager)Tata Consultancy Services Aug 2020 - Apr 2022Mumbai, 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 -
Subject Matter Expert - Clinical Operations (Business Process Lead)Tata Consultancy Services Aug 2018 - Jul 2020Mumbai, 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 -
Team Lead - Rbm (Business Process Lead)Tata Consultancy Services Oct 2017 - Jul 2018Mumbai, 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 -
Clinical Research AssociateBoehringer Ingelheim May 2016 - Sep 2017Mumbai, 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 -
Clinical Research AssociateSanofi Jul 2014 - Apr 2016Mumbai, Maharashtra, IndiaFunctioning as CRA on global, local clinical trials and registry studies, involved in site selection, monitoring, closeout, QC visits. -
Senior Clinical Project AssociateSanofi Apr 2014 - Jul 2014Mumbai, Maharashtra, IndiaFunctioning as in-house CRA for conduct of global, local clinical trials and registry studies.Mentoring Clinical Project Associates. -
Clinical Project AssistantSanofi Jan 2012 - Apr 2014Mumbai, Maharashtra, IndiaFunctioning as in-house CRA for conduct of global, local clinical trials and registry studies.Mentoring Clinical Project Associates. -
Intern Site Identification And FeasibilityQuintiles Oct 2010 - Apr 2011Mumbai, Maharashtra, IndiaFunctioning 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
Saurabh Mhatre Education Details
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Clinical Research -
Clinical Research Management -
Microbiology
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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Saurabh Mhatre
A Trained Architect With A Masters Degree In Urban Design, Bartlett School Of Architecture, Ucl.Mumbai -
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Saurabh Mhatre
Navi Mumbai -
Saurabh Mhatre
Mumbai
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