Stephanie S.
Clinical Operations Professional Supporting Global Oncology Trials | Trial Management | Study Metrics 🧬🧿 | Creative 🎨ðŸ§
- Role
- Senior Study Associate at Daiichi Sankyo US
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Stephanie S.
Clinical Operations professional with 5+ years of experience supporting global Phase oncology clinical trials. Expertise includes Clinical Trial Management support, TMF Oversight, CRO and Vendor Management, Study Metrics & Risk Identification, CTMS tracking, eTMF Quality Control, and Inspection Readiness.Experienced in facilitating cross-functional and CRO study meetings, tracking study milestones and enrollment deliverables, and supporting Sponsor Functional QC activities. Strong foundation in ICH-GCP compliance and regulatory processes.Currently focused on growing into a Study Manager role with expanded responsibility in global study oversight and operational execution.
Experience
Senior Study Associate
Oct 2023 — Present
Partner with Study Delivery Leads, Study Managers and cross-functional teams to drive study execution • Manage study operational trackers and milestone oversight within CTMS • Lead coordination of sponsor–CRO operational alignment meetings • Oversee TMF inspection readiness activities
Education
Rutgers University
Bachelor's degree, Biology/Biological Sciences, General
Middlesex College
Associate's degree, Biology, General
Harvard Online
Certificate , Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
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