Senior Clinical Research Associate / Clinical Study Manager
Job Description
Job title: Senior Clinical Research Associate / Clinical Study Manager
Department: Research & Development
Location: Southampton, UK
GLS: T03
Working hours: 37.5 hours per week Monday to Friday (onsite)
A brighter future awaits you
Job Summary
You’ll be responsible for the operational leadership and delivery of assigned ophthalmic medical device clinical studies throughout the study lifecycle, from concept and study design through start-up, execution, close-out and reporting.
Working in close partnership with Clinical Scientists and cross-functional stakeholders, the Senior Clinical Research Associate acts as the operational study lead for assigned studies, providing expertise in study planning, site selection, budget development, vendor oversight, risk management, clinical monitoring strategy, and investigator engagement to ensure successful study delivery in compliance with GCP, SOPs and applicable regulations.
Essential Functions & Accountabilities
Operational Study Leadership & Study Management
- Act as the operational study lead for assigned clinical studies, providing end-to-end study management from start-up through close-out and reporting.
- Lead study planning and delivery, including timelines, budgets, enrolment strategies, risk management and operational execution.
- Provide operational input into study design, protocol development, feasibility assessments and study execution strategies.
- Build strong partnerships with investigators, study coordinators, Clinical S...
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