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Mahesh Nagpal
Manager – Clinical Operations
Manager – Clinical Operations
Clinical Operations Manager with 12+ years of experience overseeing global clinical trials across the US, EU, and APAC regions. Proven expertise in centralized and remote monitoring, global project management, and cross-functional team leadership. Strong track record in Phase I–IV clinical studies, BA/BE trials, and medical device research, ensuring adherence to ICH-GCP and regulatory requirements. Known for driving process improvements, optimizing resource allocation, managing database lock activities, and ensuring audit/inspection readiness (USFDA, ANVISA). Adept in mentoring high-performing teams and utilizing EDC/CTMS/eTMF platforms to ensure operational excellence and data quality.
FORMERLY AT
IQVIA RDS (India) Pvt. Ltd.
LOCATION
Mumbai
AVAILABILITY
Full-time
Skills
CTMS
EDC Systems
eTMF
InForm
IVRS/IWRS
Medidata Rave
MS Office
MS Office Suite
WDCS
Wingspan
Work Experience
Manager – Clinical Operations
IQVIA RDS (India) Pvt. Ltd.
Jun 2018 – Present
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Manage and mentor a team of 15+ clinical research professionals across global studies.
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Oversee trial delivery ensuring quality, productivity, protocol adherence, and ICH-GCP compliance.
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Lead performance appraisals, resource allocation, and competency development programs.
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Support cross-functional coordination to meet financial, operational, and delivery milestones.
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Drive departmental initiatives focused on process improvement, risk mitigation, and audit readiness.
TECHNOLOGIES
Medidata Rave, Inform, IVRS/IWRS, CTMS, eTMF, WDCS, Wingspan, MS Office Suite
Centralized Monitoring Lead & Clinical Lead
IQVIA
Dec 2014 – Jun 2018
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Led centralized monitoring and remote data review activities for 100+ global clinical trial sites.
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Developed Monitoring Plans, SDV Plans, and operational manuals for study execution.
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Performed remote SDV, protocol compliance assessments, and risk-based monitoring analytics.
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Led eTMF oversight, site communications, subject recruitment tracking, and issue resolution.
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Managed a team of Clinical Analysts ensuring consistent project delivery and quality metrics.
TECHNOLOGIES
EDC (Medidata Rave, Inform), CTMS, eTMF platforms, RBM dashboards, MS Office
Clinical Research Associate
Envision Scientific Pvt. Ltd.
Jun 2012 – Dec 2014
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Conducted monitoring visits (PSSV, SIV, SMV, SCV) ensuring compliance with protocol and ICH-GCP.
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Performed source document verification, CRF review, and query resolution.
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Managed IP accountability, SAE reporting, and site closure activities across assigned sites.
TECHNOLOGIES
EDC systems, eTMF, CTMS, MS Office
