Source One is a staffing services company and we’re currently looking for the following individual to work as an employee of our direct client, a global medical device company in San Ramon, CA.
Title: Senior Clinical Scientist
Target Salary Range: 150K to 162K
Travel: Occasional travel to clinical sites as needed
Job Summary: Manage advanced clinical research studies for product development initiatives in the contact lens industry.
Essential Functions & Accountabilities:
• Plans and manages all aspects of clinical evaluation of product performance, including study design, clinical protocol writing, clinical study execution, performing or oversight of statistical analysis, clinical report writing, results delivery and participation in R&D technical teams, under direction of clinical management.
• Coordinates standardized clinical protocol execution with established clinical research centers.
• Strong research design knowledge, hypothesis testing and technical communication.
• Aware of literature and other knowledge related to contact lenses.
• Aware of basic regulatory requirements related to medical devices (GCP / IRB / Design Control / FDA & ISO standards / EU MDR, etc.) and applies knowledge under direction of clinical management.
• Conducts basic clinical assessments; serves as Sub-Investigator under direction of Principal Investigator.
• Actively apply learnings from prior experience, current trends in clinical research, and competitor awareness to product development activity and/or invention applications; publishes or presents in scientific forums as needed.
Qualifications:
• Research design, statistical analysis, medical writing, GCP and Design Control knowledge
• Understand biological and optical contributors to contact lens safety and performance
• Optometry/ Ophthalmology knowledge and experience desirable
• Attention to detail, systematic and orientation toward careful meticulous work
• Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology
• Ability to quickly assimilate and apply new information
• Working knowledge of computer operating systems
• Strong Excel database skills
• Well-organized, ability to multitask and adjust to changing priorities
Work Environment:
• Normal office environment and ophthalmic clinical exam room
• Sedentary to light physical effort necessary to perform the job
• Extensive contact with employees and outside researchers
Experience:
• Experience in the contact lens industry required
Education:
• OD or equivalent + MS or OD or equivalent + 2 years or PhD + 2 years
• Clinical or Research degree in Vision Science or Visual Optics or Physiological Optics, or Optometry/ Ophthalmology highly preferred
• Clinical licensure in CA desirable, but not mandatory
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