What are the responsibilities and job description for the Senior Clinical Data Management Specialist position at Glaukos Corporation?
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.
Responsibilities:
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
INTERNAL GOVERNANCE
* 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
Work Experience:
* 5 - 8 years of experience in Clinical Data Management in the medical device/pharmaceutical/biotechnology/CRO setting.
* Preferred experience in Ophthalmology Therapeutic area.
Education:
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 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.