Senior Clinical Research Associate/Clinical Study Manager

CooperVision

Southampton, United Kingdom

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 Scientists and teams across Regulatory, Quality, Legal, Procurement and Finance.

Site, Vendor & Clinical Monitoring Oversight

Identify, qualify, activate and oversee high-performing investigative sites.
Develop and implement risk-based monitoring strategies and conduct site qualification, initiation, monitoring and close-out visits.
Oversee CROs, vendors and external partners, ensuring delivery against quality, timeline, budget and contractual expectations.
Monitor site performance, enrolment and study risks, taking timely action to resolve issues and protect participant safety and data quality.

Quality, Compliance & Documentation

Ensure studies are delivered in accordance with Good Clinical Practice (GCP), ISO 14155, company procedures and applicable regulatory requirements.
Maintain inspection-ready Trial Master Files (TMFs) and essential study documentation.
Support ethics and regulatory submissions, audits and inspections.
Contribute to the continuous improvement of clinical processes, templates and ways of working.

Knowledge, Skills and Abilities, Experience

Experience developing study plans, timelines, budgets, enrolment strategies and risk-management plans, including developing and managing study budgets and supporting study-related financial planning activities.
Demonstrated experience acting as the operational lead for one or more clinical studies, with responsibility for study planning, execution, vendor oversight, budget management, risk management and study delivery.
Strong knowledge of risk-based monitoring principles and experience developing and refining monitoring plans, including proactively identifying, assessing and mitigating study risks.
Experience supporting ethics and regulatory submissions, clinical trial registrations, study contracting activities and investigator payments.