Senior Clinical Research Associate & Clinical Study Manager

About the role

You will lead the operational delivery of ophthalmic medical‑device clinical studies from concept through to reporting. Working closely with Clinical Scientists and cross‑functional teams, you act as the operational study lead, ensuring studies are executed on time, within budget and in compliance with GCP and regulatory standards.

Key responsibilities

• Act as operational study lead, managing study planning, timelines, budgets, enrolment strategies and risk management.
• Provide input into study design, protocol development and feasibility assessments.
• Identify, qualify and oversee investigative sites, develop risk‑based monitoring plans and conduct site visits.
• Oversee CROs, vendors and external partners, ensuring quality, timeline and contractual compliance.
• Maintain inspection‑ready Trial Master Files and support ethics, regulatory submissions and audits.
• Drive continuous improvement of clinical processes and documentation.

Required profile

• Proven experience developing study plans, budgets, enrolment and risk‑management strategies.
• Demonstrated track record as operational lead for one or more clinical studies.
• Strong knowledge of risk‑based monitoring principles.
• Experience supporting ethics and regulatory submissions, trial registrations and investigator payments.
• Bachelor's degree in a scientific, life‑sciences, healthcare or clinical research discipline.

Required skills

• Good Clinical Practice (GCP)
• ISO 14155
• Risk‑based monitoring
• Clinical trial registration
• Budget management
• Vendor oversight

What we offer

• Competitive salary and bonus scheme
• Private medical insurance and health cash plan
• 25 days holiday plus pension scheme and life assurance
• Wellness Platform, discounted contact‑lens scheme and LinkedIn Learning access