Nishita Parekh

Local Study Associate Director @精鼎医药

Toronto, CA
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2025 — Present

Local Study Associate Director @精鼎医药

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EDUCATION

2023

University of Toronto - Rotman School of Management

Global Executive MBA, Healthcare and Life Sciences

2006

Western University

Bachelor of Medical Sciences, Microbiology & Immunology

2014

University of Toronto

Post Graduate Certificate, Project Management

2007

Humber College

Post Graduate Certificate, Clinical Research

SKILLS

EdcCtmsRegulatory AffairsPharmacovigilanceGood Clinical Practice (Gcp)MedicineClinical DevelopmentMedidataRegulatory SubmissionsClinical Data ManagementOncologyProtocolIrbCROClinical TrialsClinical ResearchClinical Study DesignResearch EthicsCrf DesignSopClinical Trial ManagementPhase IHematologyTrial ManagementImmunologyData ManagementClinical MonitoringClinical Trial Management System (Ctms)Informed ConsentIch-GcpOncology Clinical ResearchInfectious DiseasesProtocol ReviewDrug DevelopmentGcp

ABOUT NISHITA PAREKH

Clinical Operations Leader | Patient-Centric | Delivering Trials with Precision and Quality I am passionate about advancing patient-centric research through adaptive, data-driven strategies that accelerate innovation while maintaining rigorous quality and compliance standards. With 17+ years in clinical research, including complex Phase trials in oncology, cellular therapies, and infectious diseases; I specialize in designing workflows that convert complex protocols into real-world executable, inspection-ready solutions. I complement my clinical research expertise with solid business training, enhanced leadership, and a proven ability to align operational execution with financial and strategic objectives. Strategic Leadership Highlights: • Managed clinical operations portfolios spanning 300+ trials • Led cross-functional teams of 80+ research professionals • Implemented enterprise-wide operational standardization • Drove $3M+ operations and clinical research budgets with precisionOperational Excellence: • End-to-end trial lifecycle management • Risk-Based Monitoring (RBM) implementation • Regulatory compliance across FDA/ICH-GCP standards • Digital transformation of clinical research processesKey Competencies:• Global Clinical Operations Strategy• Cross-Functional Team Leadership• Vendor/CRO Partnership Management• Clinical Technology Integration• Regulatory Audit PreparationUnique Value Proposition: Bridging site-level insights with sponsor-side strategic execution to optimize clinical trial performance and patient outcomes.Open to: Senior Clinical Operations, Trial Management, Consulting, and R&D Leadership roles.

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Nishita Parekh — Local Study Associate Director at 精鼎医药 in Toronto, CA | Unifers