Clinical Trial Manager - USA
|Discipline:||Research & development|
|Job type:||Permanent Full Time|
|Published:||about 1 month ago|
Purpose of role
Rayner is a leading developer and manufacturer of ophthalmic implants and pharmaceuticals with global headquarters in Worthing, UK. We specialize in the design and manufacture of intraocular lenses (IOLs) and related products, such as OVDs and pharmaceuticals used in cataract and refractive surgery. Since the manufacture of the world’s first IOL by Rayner in 1949, we have continuously pioneered IOL design with a goal of improving vision and restoring sight worldwide. The first ever FDA- approved IOL was a Rayner lens. Today, over 26 million IOLs are implanted around the world every year, and it is globally the most performed elective surgical procedure. Our mission is simple: to deliver excellent visual outcomes for patients and surgeons.
Since Rayner was founded in 1910, we have established a reputation for innovation and product excellence. Rayner has over 400 employees in the UK, Germany, Austria, Switzerland, Spain, Portugal, Italy, US, Canada, Malaysia and India. Today, we have offices in New York and Memphis. Rayner Surgical Inc and Omeros Corporation have announced the signing of an agreement to transfer Omeros’s ophthalmology assets, including OMIDRIA and the teams to support the product to Rayner and subject to usual closing conditions, the deal is expected to close on or before Dec 31, 2021. Rayner will open an office in Seattle and the OMIDRIA team will be a big part of our growth.
In this role, you will be responsible for the clinical research activities on Rayner ophthalmic medical products within the Eye Science Team. These include planning, managing, and executing of Rayner manufacturer sponsored clinical trials for the registration purposes, PMCF and marketing studies and providing oversight and support for Investigator Initiated trials and commercial evaluations.
Key activities and accountabilities
* Overall responsibility of clinical trials design and management for international submissions. Ensuring that studies (clinical and pre-clinical) are appropriately designed, timely approved, monitored and successfully executed.
* Developing and maintaining of trials documentation (Clinical Investigation Protocol (CIP), Investigator Brochure, Patient Informed Consent Form, and (e) Case Report Forms, Accountability Log, TMF, etc. in compliance with actual requirements, standards, specifications regulations, and guidelines, where applicable (MDR 2017/745. MPG, ICH GCP E6, NMPI, ISO 14155:2020, ANSI Z80.x ISO 11979-7, 21CFR812).
* Active support and management of CROs (when applicable) in trials approval applications, communication and reporting to Institutional Review Boards, Competent Authorities, sites monitoring and overall trial conduction to timely identify, and evaluate issues, proactively recommend solutions to ensure studies approvals and compliance to the national, regulatory requirements, studies objectives, and timelines.
* Driving trials management and clinical operations by identifying, and effectively controlling risks and opportunities in a clinical trials environment
* The overall efficient day-to-day management of the trials/vendors. When applicable, training trial sites on CIP requirements, ISO 14155:2020.
* Provision of clinical/regulatory expertise to Rayner Eye Science team for the development of clinical trial documents and SOPs
* Assist with clinical trial budget planning and vendors selection and contracts development. Communicate and manage vendors to ensure quality, studies timelines, and objectives.
* Coordinating various clinical projects across different vendors.
* Liaising with key stakeholders, internally and externally. Communication and providing clinical support and expertise to Marketing, R&D, Regulatory and Quality teams, ophthalmic society KOLs, and research organizations.
* 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.
* Working with marketing, commercial teams and KOLs, to enhance Rayner scientific share of voice.
* Ambition: We play to win.
* Focus: We put patients first.
* Integrity: We keep our promises.
* Openness: We are passionate about new ideas.
* Respect: We support each other.
Core and role specific competencies
* Motivation: Displays energy and enthusiasm in approaching the job. Commits to putting in additional effort. Maintains high level of productivity and self-direction. Learning, Results and Quality oriented.
* Clinical competence: Knowledge and experience in medical devices clinical trial design and process. Competent in analyzing and interpretation of pre-clinical and clinical data. Medical Writing.
* Planning & Organizing: Plans and organizes tasks and work responsibilities to achieve objectives and meet timelines. Sets priorities. Schedules activities. Allocates and uses resources properly
* Teamwork: Interacts with people effectively, openly. Able and willing to share and receive information, develop trust and integrity with team crew.
* Communication: Communicates effectively, listens sensitively, adapts communication to audience and fosters effective communication with internal and external stakeholders
* Adaptability: Adjusts to changing environments whilst maintaining effectiveness
* Commercial Awareness: Understands and keeps up to date with the international ophthalmic industry and business in general, including marketing trends, customer demographics, technical advances, and the successes and failures of competitors.
* Degree in medical, natural, technical or life science or health related field, with extensive experience in doing research for medical devices or pharma industry
* Demonstrated at least 3-5 years’ experience in medical devices clinical research. Solid understanding of clinical trial regulations, international standards methodology.
* Strong project management expertise. Ability to travel
* Excellent English writing and communication skills. Multiple languages knowledge is an advantage.
* Self-driven, accountable, and collaborative team player
* Ophthalmology, Project management experience
* IOLs experience, knowledge of FDA, NMPI, ANSI Z80.x ISO 11979-7 clinical requirements
* Previous industry, CRO or start-up company experience
* Demonstrated hands-on experience of managing CROs, external vendors.
* Experience in statistical analysis
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