Senior Clinical Research Associate / Clinical Study Manager
Cooper Companies · Southampton
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 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.
Full Job Description available on request
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.
Education/Qualifications
- Bachelor's degree in a relevant scientific, life sciences, healthcare or clinical research discipline.
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including, bonus, private medical, health cash plan, 25 days holiday, pension scheme, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop your career and grow with CooperVision.
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1to view all other opportunities.
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