Senior Clinical Data Management Specialist
- San Clemente, CA
The Sr. Clinical Data Management Specialist, based in San Clemente (eventually relocating our Headquarters to Aliso Viejo, CA), works in coordination with Data Management, Biostatistics, Programming and Clinical Operations teams. Experienced personnel is responsible for in-house data review support. Experience with data management on phase 1-3 and post marketing trials. The individual will participate in all data management activities from study start up to close out activities, and during the course of the study would clean data and organize the cleaning efforts supporting human research studies for medical devices and pharmaceuticals developed by Glaukos Corporation. This individual must possess good analytical skills and have the ability to review data using various tools.
CLINICAL DATA REVIEW AND EXECUTION
• Authoring of clinical data management documents such as data management plan, CRF completion guidelines, data review guidelines
• Responsible for the development of eCRF design and annotation, database design specifications and data review listings
• Responsible in the validation activities such as user acceptance testing (UAT) of clinical databases
• Responsible for data cleaning efforts and perform regular in-house data review across all Glaukos studies. Perform data review to identify quality issues, data trends and generate queries as necessary.
• Responsible for the receipt and handling of data received from external sources and perform data reconciliation where applicable
• Work with programming to produce customized reports or data listings to facilitate data review and cleaning (e.g. safety reviews).
• Generate reports or data listings to track study progress
• Prepare Data Management training materials for Investigator meeting, internal and external teams
• Maintains CDM project documentation including vendor files in an audit-ready manner
• Contribute to the development and implementation of departmental initiatives
• Participation in the standardization of operational processes, data collection systems to improve data quality deliverables
• Assist in Project Planning
• 5 - 8 years of experience in Clinical Data Management in the medical device/pharmaceutical/biotechnology/CRO setting.
• Preferred experience in Ophthalmology Therapeutic area.
Bachelor's Degree in biological science, nursing or other health-related discipline preferred.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
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