Clinical Operations Manager
10 hours ago
London
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 Compliance • Develop Strategies for Effective Clinical Data Generation, • Oversee 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 Training • Develop 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 Oversight • Select, contract, and manage CROs or other relevant vendors, • Ensure quality control, timely reporting, and adherence to study objectives., • Coordinate trial operations, from site selection and monitoring to study closure. Data Management & Risk-Based Monitoring • Oversee 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 Leadership • Work 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 Support • Collaborate 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 Optimization, • Assist 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 package, • Global appreciation platform to recognise colleagues around the globe, • Fantastic opportunity to work with highly talented teams and individuals and grow with the business, • Being part of an organisation you can be proud to work for changing the lives of millions of people!