Senior Clinical Scientist - PMS
Job Summary
Manage post-market clinical research studies for product life cycle initiatives in the contact lens industry.
Key Duties
* Plan and manage all aspects of clinical evaluation of products, including write and/or reviewing protocols and related study materials, overseeing study execution, perform or oversee statistical analysis, write and/or review study reports.
* Participate in broader product management teams (commercial/marketing, professional affairs, regulatory affairs, quality assurance, etc.) under direction of clinical management.
* Strong research design knowledge, hypothesis testing and technical communication.
* Aware of literature and other knowledge related to contact lenses.
* Aware of basic ethics and regulatory requirements related to medical devices (GCP/ IRB/EC / FDA & ISO standards/ EU MDD/MDR, etc.) and applies under direction of clinical management.
* Actively apply learnings from prior experience, current trends in clinical research, and competitor awareness to product life-cycle activity
* Publishes or presents in scientific forums, as appropriate.
Qualifications/Key Skills
* Optometry/ophthalmology knowledge/experience is beneficial
* Understand biological and optical contributors to contact lens safety and performance.
* Research design, statistical analysis, medical writing, clinical research ethics and regulatory knowledge.
* Attention to detail and orientation toward careful, meticulous work.
* Ability to manage multiple projects and adjust to changing priorities.
* Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.
* Ability to quickly assimilate and apply new information.
* Solid Microsoft Office skills (Word, Excel, Teams, etc.)
Experience & Education
* 5+ years clinical experience
* PhD qualification ideally or Master’s Degree
* Experience in contact lens or medical device industry favourable.