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 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!