Saurabh Mhatre

About Saurabh Mhatre

With over 15 years of hands-on experience in Global Clinical Trials across diverse therapeutic areas and study phases, I’ve developed expertise in Clinical Trial Management, Risk Based Quality Management (RBQM), Vendor Management and Decentralized Clinical Trials. I have working understanding of implementing technology driven solutions including eConsent, eISF. I am part of the team involved in training governance helping new team members for success. I thrive on delivering impactful results that improve efficiency and compliance. As a Clinical Trial Manager, I’ve contributed to multiple Clinical Trial Plans and led diverse cross-functional teams to ensure seamless study delivery, from protocol review to study closure. My expertise extends to developing Key Risk Indicators (KRI), monitoring study Quality Threshold Limits (QTL) and developing risk mitigation strategies that ensure smooth conduct of clinical trials. I 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 on industry sponsored 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 am interested in 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 oversight, or ensuring eTMF audit readiness, I’m committed to enhancing efficiencies in clinical trial management.

Experience

1. Global Clinical Trial Manager (Centralized Monitoring Manager)

   IQVIA

   May 2022 — Present · Mumbai, IN

   Functioning as Operational Lead, the day to day conduct of the Clinical Trials across Start up, Conduct and Close out.• Developing and executing Trial Operational Plans including Monitoring, Risk Management, Protocol Deviation Management, Access Management, IP cold chain management aligned to ICH GCP and sponsor SOPs.• Leading a team of Clinical Research Associates (CRA) and Central Monitors (CM) towards effective Clinical Monitoring to ensure Protocol Adherence.• Collaborating with Sponsor for Patient Recruitment and Retention strategies.• Review Monitoring Reports and Quality Tolerance Limits (QTL) and drive Corrective and Preventive Actions (CAPA).• Reviewing Study Budget and overseeing Resource Management for Clinical Operations team.• Provide project specific training, track deliverables and manage performance issues or escalations.• Managing Study Metrics including Action Items, Protocol Deviations, Monitoring Visit and Report (MVR) timelines, Trial Master File (TMF) audit readiness, Site Payment approvals.• Leading Data Analytics team to setup and oversee Risk Based Monitoring metrics.• Partnering with Study Start-up teams from Site Selection till Activation as per Study Timelines.• Partnering with Vendor POCs for Trial Supplies and System Access management.Key Initiatives:• Subject Matter Expert for eConsent and eISF implementation.• POC for departmental onboarding assessment and mentor allocation

Education

• INSTITUTE OF CLINICAL RESEARCH PROFESSIONALS (INDIA)

  Post-Graduate Diploma, Clinical Research Management

  2009

• Institute of Clinical Research India

  Postgraduate Degree, Clinical Research

• Cranfield University

  Master of Science - M Sc, Clinical Research

  2010

• University of Mumbai

  Bachelor of Science - BSc, Microbiology

  2007

• University of Mumbai

  Bachelor of Science, Microbiology, General

• Cranfield University

  Master of Science, Clinical Research