• Job Description

  Req#: 1491

  How will you make an impact?

  The Sr. Clinical Data Management Specialist, based in Aliso Viejo, 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.

  What will you do?

  Clinical Data Review and Execution

  • Requires cross-functional interactions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory
  • 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

  Data Review:

  • At the direction of the Lead Clinical Data Manager perform regular data review across Glaukos studies to identify quality issues, data trends/outliers and generate queries as necessary.

  Data Management Documentation:

  • Participate in the updating of the Data Management Plans, Data Review Guidelines and CRF Completion Guidelines.

  User Acceptance Testing:

  • At the direction of the Lead Clinical Programmer, perform User Acceptance Testing (UAT) of the clinical databases including EDC.

  Collaboration with Cross-Functional Teams:

  • At the direction of the Lead Data Manager, provide ongoing day-to-day support to Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
  • Collaborate with internal team and stakeholders to ensure deliverables meet timelines.

  Process Improvement:

  • Recommend process improvements related to their job responsibilities that can be used or developed to increase efficiency.

  How will you get here?

  • 5 – 8 years of experience in Clinical Data Management in the medical device/pharmaceutical/biotechnology/CRO setting.
  • Bachelor’s Degree in biological science, nursing or other health-related discipline preferred.
  • Preferred experience in Ophthalmology Therapeutic area.

  Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

  These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

  Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

  We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!

  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.
  

  #GKOSUS

• About the company

  Glaukos works relentlessly to create and deliver transformative therapies for patients struggling with glaucoma, corneal disorders, and retinal diseases.

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