The Manager, Clinical Affairs – Retina & Glaucoma is responsible for the management of Company retina and glaucoma related regulated clinical studies in support of marketing applications in the United States and other countries as required. This individual is responsible for study design and implementation, including protocol development, case report form development, data monitoring, data analysis, report writing, and interfacing with study sites. This individual will support the timely preparation and submission of Institutional Review Board (IRB) applications, Ethics Committee applications, 510 (k) Premarket Notifications, and other regulatory submissions necessary for clinical and marketing authorizations. This individual may participate on project teams to ensure that Company objectives are met.
- Supervises the clinical studies activities of the Clinical Research Scientists and Clinical Research Associate(s) assigned to the retina and glaucoma business sectors.
- Oversees the development of clinical study protocols and case report forms, clinical trial monitoring, data analysis, and reports for product development and regulatory submissions.
- Assures accurate records are maintained and provides periodic reports.
- Interfaces with clinical investigators and IRBs to ensure timely completion of clinical studies and submission of marketing applications.
- Conducts clinical site audits and internal audits, as necessary to support regulated activities.
- Works collaboratively with R&D, Marketing, Regulatory, Professional Relations, and other departments to ensure appropriate clinical and regulatory activities to support Project Teams.
- Maintains and works to Company SOP’s. Ensures that procedures are adequate for conducting regulated clinical trials. Develops and implements procedures and work instructions, as necessary, to ensure conformance with Good Clinical Practices.
- Reviews promotional and educational materials for appropriate clinical content.
- Supports Product Complaint investigations.
- BS degree in an appropriate discipline or equivalent.
- Degree in optometry or ophthalmology preferred.
- Five years of experience in an FDA-regulated environment.
- Experience with a manufacturer of ophthalmic products preferred.
- Must be willing to travel overseas approximately 3x a year.
Carl Zeiss Meditec, Inc. is an Equal Opportunity Employer (EOE) and strongly supports diversity in our workplace.
Qualified candidates may apply by submitting a resume to firstname.lastname@example.org. Please reference requisition #R1357JM in the subject line.