Ophthalmic Clinical Study Lead – Senior CRA (Hybrid)

CooperVision; Southampton; Híbrido; GBP 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus potential

Private medical

Health cash plan

25 days holiday

Pension scheme

Life assurance

Wellness Platform access

Discounted contact lenses

Descripción de la vacante

CooperVision in Southampton (UK) seeks a Senior Clinical Research Associate / Clinical Study Manager to lead ophthalmic medical device trials from design through reporting. You will partner with Clinical Scientists and cross-functional teams to ensure delivery in line with GCP, ISO 14155 and applicable regulations. The role covers study planning, site selection, budget development, vendor oversight, risk management and investigator engagement, with hybrid onsite work.

Formación

• Experience leading clinical studies from start-up to close-out and reporting.
• Strong knowledge of risk-based monitoring and budgeting for trials.
• Experience supporting ethics and regulatory submissions and investigator payments.
• Ability to build partnerships with investigators, CROs and cross-functional teams.

Responsabilidades

• Act as the operational study lead for assigned clinical studies from start-up through close-out and reporting.
• Lead study planning with timelines, budgets, enrolment strategies and risk management.
• Develop and implement monitoring plans and oversee site qualification, initiation, monitoring and close-out visits.
• Oversee CROs and vendors to ensure quality, timeliness and contractual alignment.

Conocimientos

Study leadership

Budget management

Risk management

Site qualification & monitoring

Vendor management

Regulatory compliance

GCP & ISO 14155 knowledge

Educación

Bachelor's degree in a relevant scientific, life sciences, healthcare or clinical research discipline

Herramientas

EDC systems

TMF systems

Descripción del empleo

CooperVision in Southampton (UK) seeks a Senior Clinical Research Associate / Clinical Study Manager to lead ophthalmic medical device trials from design through reporting. You will partner with Clinical Scientists and cross-functional teams to ensure delivery in line with GCP, ISO 14155 and applicable regulations. The role covers study planning, site selection, budget development, vendor oversight, risk management and investigator engagement, with hybrid onsite work.