Clinical Operations Manager

We are expanding our team here at Rayner Reporting into the Global Director, Clinical Research, the Clinical Operations Manager will be a truly collaborative professional, working closely with KOLs, investigators, and ophthalmic research organizations to provide scientific advice to both internal and external stakeholders.What You'll Be Doing:Clinical Trial Management & Regulatory ComplianceDevelop Strategies for Effective Clinical Data GenerationOversee the design, execution, and approval of global clinical and preclinical trials for ophthalmic medical devices.Ensure adherence to ISO 14155:2020, ISO 11979:2024, MDR 2017/745, ICH GCP, 21 CFR 812, ANSI Z80.x, and national regulatory requirements.Manage submissions to ECs and CAs (e.g., EMA, MHRA, BfArM, AEMPS).Ensure compliance with GDPR for data protection in clinical trials, including handling of patient data, informed consent, and data transfer regulations.Clinical Documentation & Site TrainingDevelop and maintain CIP, IB, ICF, CRFs, TMF, and Accountability Logs.Provide ISO 14155:2020 training to clinical trial sites and ensure protocol adherence.Ensure compliance with GDPR in data collection, processing, and anonymization.CRO & Vendor OversightSelect, contract, and manage CROs or other relevant vendorsEnsure quality control, timely reporting, and adherence to study objectives.Coordinate trial operations, from site selection and monitoring to study closure.Data Management & Risk-Based MonitoringOversee data collection, validation, and analysis using EDC platforms.Implement RBM to optimize trial efficiency and compliance.Conduct interpretation, analysis and summary of clinical data, focusing on ophthalmic surgical postoperative outcomes.Stakeholder Collaboration & Scientific LeadershipWork closely with KOLs, investigators, and ophthalmic research organizations to provide scientific advice to both internal and external stakeholders.Provide clinical support to internal teams (R&D, Regulatory, Quality, Marketing, etc.Support Rayner share of Voice in scientific conferences, regulatory discussions, and advisory boards. Assist the Clinical Compliance team by providing clinical data to support registration dossiers and regulatory submissions.Marketing & Commercial SupportCollaborate with marketing, commercial teams, and field product specialists to enhance Rayner’s scientific share of voice, support tender applications, and contribute to reimbursement programs.Trial Budgeting & Process OptimizationAssist with budget planning, vendor contract development, and cost control.Drive process improvements in clinical trials, leveraging digital innovations.What Experience & Skills You Will Need:Degree in medical, natural, technical, life sciences, or health-related fields, with extensive experience in medical device or pharmaceutical research.3-5 years of experience in ophthalmic clinical research, including clinical trial design, execution, and regulatory compliance.Extensive expertise in ophthalmic clinical trials and global medical device regulations (ISO 14155, MDR, FDA 21 CFR, GDPR.Strong understanding of ophthalmic clinical methodologies, including visual acuity testing contrast sensitivity, defocus curves, and surgical postoperative outcomes.Expertise in ophthalmic data analysis.Demonstrated ability to interpret and communicate ophthalmic clinical data for regulatory submissions and scientific publications.Strong project management expertise in ophthalmology clinical trials, including site selection, monitoring, and CRO/vendor management. Ability to travel as required.Excellent English writing and communication skills; proficiency in additional languages is an advantage.Self-driven, accountable, and a collaborative team player, capable of working independently and cross-functionally.What We Can Offer You:Comprehensive benefits packageGlobal appreciation platform to recognise colleagues around the globeFantastic opportunity to work with highly talented teams and individuals and grow with the businessBeing part of an organisation you can be proud to work for changing the lives of millions of people