Clinical Trial Specialist

Job content

Rayner is a leading developer and manufacturer of ophthalmic implants and pharmaceuticals; it specialises in intraocular lenses (IOLs) and related products used in cataract surgery and refractive surgery. Since the development of the first IOL, Rayner has continuously pioneered IOL design with a goal to improve vision and restore sight worldwide.

Today, Rayners mission remains to deliver innovative and clinically superior ophthalmic solutions that respond to the expectations of our global customers to improve sight and quality of life for their patients.

This is a great opportunity to manage the clinical research activities within the Eye Science team, including company and investigator sponsored research and commercial/observational evaluations.

Working closely with KOLs, the global clinical and marketing teams and our in-field product specialists, the role of the Clinical Trial Specialist is to support the management of Rayner ophthalmic solutions and clinical research activities across the Rayner surgical business. Please note this role can also be based in Berlin.

Key Responsibilities:

• Overall responsibility of site/investigator selection and trial design for international submissions. Ensuring that studies (clinical and pre-clinical) are appropriately designed, approved, monitored, and executed
• Developing and maintaining trials documentation; Clinical Investigation Protocol (CIP), Investigator Brochure, Patient Informed Consent Form, and (e) Case Report Forms, etc. ensuring compliance with standards and specification regulations (MDR 2017/745. MPG, ICH GCP E6, ISO 14155 21CFR812)
• Conducting trial approval applications, communications and reporting to Ethics Committees/ Institutional Review Boards, and Competent Authorities
• Training trial sites on CIP requirements, ISO 14155; overseeing sites and monitoring of trial progress to ensure compliance with and adherence to the CIP. Identify and evaluate issues, proactively recommending solutions to meet study objectives and timelines
• Assist with clinical trial budget planning and vendor contracts development. Manage vendors to ensure quality, study timelines and objectives are met
• Co-ordinating various clinical projects across different vendors and stages of product development
• Provide clinical support to Marketing, R&D, Regulatory and Quality teams, the Ophthalmic society and research organisations
• Conduct analysis and reporting of trial data, including RWE/commercial evaluations
• Working with marketing and commercial to enhance KOL relationships

Experience:

Essential

• Undergraduate degree within related subject
• Extensive experience in medical device clinical research. Solid understanding of clinical trial regulations, international standards, and methodology
• Facilitation/management of clinical investigations of medical devices
• Evidence of developing or following systems for monitoring performance in research studies/programmes
• Project management expertise
• Excellent communication skills
• Advanced level of English language

Desirable

• Ophthalmology
• IOL experience, knowledge of FDA, NMPI, ANSI Z80.x ISO 11979-x clinical requirements
• Previous hospital, CRO or start-up company experience
• Experience of managing CROs, external vendors
• Statistical Analysis