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Clinical Data Manager

Company: Glaukos
Location: San Clemente
Posted on: June 10, 2021

Job Description:

How will you make an impact?

The Clinical Data Manager, based in San Clemente, CA, eventually based in Aliso Viejo, CA is responsible for study Data Management activities from study start up to close out. Providing input into the data cleaning strategy and aiding data cleaning efforts supporting Clinical Studies. This individual must possess good project management and analytical skills and have the ability to review data using various reporting and analytics tools.

What will you do?

  • Assist with writing, reviewing and management of key documents such as Data Management Plan, Project Plan, CRF completion guidelines, edit check specifications, data review guidelines.
  • Manage the User -Acceptance Testing (UAT) of clinical databases including EDC.
  • Facilitate cross-functional meetings to support Data Management deliverables (e.g. Edit Check Specifications, CRF completion guidelines etc.)
  • Contribute to the delivery of EDC study deliverables.
  • Support data cleaning efforts and perform regular data review across Glaukos studies. Perform data review to identify quality issues, data trends/outliers and generate queries as necessary.
  • Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management
  • Perform review of study SAS and SDTM datasets.
  • Provide input and review of clinical data from external sources and assist in data reconciliation.
  • 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 medical coding, AE/SAE reconciliation.
  • Assist with 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, in-house personnel and site staff.
  • Contribute to the development of departmental processes and procedures.

How will you get here?

  • BS or higher in biological science, nursing or other health-related discipline preferred.
  • Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is preferred (BS or higher in biological science, nursing or other health-related discipline preferred.)
  • Knowledge of FDA/ICH guidelines and industry/technology standard practices
  • Knowledge of Data Management Practices and other regulatory guidelines specific to data management preferred.
  • Excellent verbal and written communication skills
  • Knowledge of Electronic Data Capture (EDC) systems (e.g. Inform, RAVE, iMedNet, etc.)
  • Hands-on ability to review data and ability to use various data review tools
  • Project Management experience
  • Experience writing technical documentation (E.g. DMP, edit check specifications etc.)
  • Attention to detail.
  • Experience with Microsoft Office tools.

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 here are empowered with more diverse and enriching challenges than 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 paid 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! Check out our profile on The Muse to get an inside look at our company culture. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 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.

Keywords: Glaukos, San Clemente , Clinical Data Manager, Other , San Clemente, California

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