Sandhya Shinde
Senior Clinical Project Manager Providing Services to Novartis Fsp @IQVIA
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WORK HISTORY
Senior Clinical Project Manager Providing Services to Novartis Fsp @IQVIA
London, GB
EDUCATION
SYMBIOSIS INTERNATIONAL UNIVERSITY
PGDEMS, Emergency Medicine
Kingston University
Masters in Pharmaceutical Science with management studies, Pharmaceutical Science with management studies
Catalyst Clinical Services
Professional Diploma, Clinical Research
The Knowlege academy
Prince2Certified
Maharashtra University of Health Sciences
BHMS, Homoeopathic Medicine and Surgery
SKILLS
ABOUT SANDHYA SHINDE
Clinical Research Professional | 17+ Years of Expertise in Clinical Operations.Highly experienced in managing Phase I–IV clinical trials across diverse therapeutic areas. Skilled in study and site management, CRO and Vendor oversight, budget/invoicing/resource allocation and Inspection readiness.Proven ability and track record in leading cross-functional teams, overseeing clinical trial operations, and ensuring regulatory compliance in multinational studies across the EU, UK, and US.Key Skills & Expertise:Vendor & CRO Management: Expertise in selecting, managing, and overseeing vendors to ensure timely and quality delivery of clinical trial services.Regulatory Compliance & Inspection Readiness: Successful preparation for FDA inspections, recently faced 3 onsite FDA inspections, maintaining continuous inspection readiness with a focus on eTMF and document management.Project & Budget Management: Adept at handling trial budgets, resource allocation, and risk management to optimise study efficiency and cost-effectiveness.Clinical Trial Leadership and management: Led multi-regional studies, managing up to 800 subjects in Phase trials, ensuring all trial milestones and regulatory requirements are met.Therapeutic Area Expertise: Extensive background in oncology, paediatrics, cardiovascular, endocrine, infectious diseases and respiratory studies.I thrive in collaborative environments, and my strong leadership skills allow me to drive teams toward achieving study objectives. With a deep understanding of clinical operations, vendor management, and regulatory processes, I am passionate about advancing medical research and ensuring successful trial outcomes.
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