Description
Primary Responsibilities:- 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
Education / Requirements:
- 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 to oversee clinical studies activities
To find out more about Real please visit www.realstaffing.com