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!