Clinical Data Reviewer
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Clinical Data Reviewer, based in San Clemente, CA is responsible for in-house data review support. Ideal candidates will be experienced 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 developed by Glaukos Corporation. This individual must possess good analytical skills and have the ability to review data using various tools. This individual will work within Clinical Operations.
Clinical Data Review and Execution:
• Requires cross-functional interactions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory.
• Support 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.
• Assist with writing, review and management of key documents such as data management plan, CRF completion guidelines, data review guidelines
• Assist in the development of eCRF design and annotation, database design specifications and data review listings
• Participate in validation activities such as user acceptance testing (UAT) of clinical databases
• Help coordinate receipt and handling of data received from external sources and assist in 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 for study teams as needed.
• Assist in coding, AE/SAE reconciliation.
• Maintains CDM project documentation including vendor files in an audit-ready manner
• Assist in the monitoring of enrollment information as collected in the database, provide status update to the study team.
• Assist with the preparation of Data Management training materials used for Investigator meetings and in-house personnel.
• Contribute to the development and implementation of departmental initiatives
• Participation in the standardization of operational processes, data collection systems to improve data quality deliverables
• Minimum 1-3 years of experience in clinical data management in the medical device/pharmaceutical/Biotechnology/CRO setting. Preferred experience in Ophthalmology Therapeutic area.
• Current in-depth knowledge of the FDA's Good Clinical Practices guideline, ICH, clinical trials monitoring and regulatory compliance
• Overall understanding of Good Data Management Practices and other regulatory guidelines specific to data management
• Hands-on ability to review data and ability to use various data review tools
• Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. Inform, RAVE, iMedNet, etc.), database design and database concepts required
• Experience with SQL, SAS, Excel or other programming language a plus
• Medical terminology (and ophthalmology terminology) helpful
• Strong analytical and problem solving skills, attention to details
• Ability to work independently with minimal supervision and collaborate with colleagues to accomplish team goals and deadlines
• Excellent written and verbal communication and presentation skills
• Motivated and able to work independently, as well as within a team
• Excellent organizational skills
• Exhibits personal integrity, credibility, and responsibility
• Perform any other related duties as assigned or required.
• Bachelor's Degree in biological science, nursing or other health-related discipline preferred.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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