Clinical Data Manager
Location: San Clemente
Posted on: June 10, 2021
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
- Facilitate cross-functional meetings to support Data Management
deliverables (e.g. Edit Check Specifications, CRF completion
- 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
- Represent Data Management in study team meetings, providing
data status metrics and providing guidance on issues related to
- 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
- Generate reports or data listings for study teams as
- 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
- Contribute to the development of departmental processes and
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
- 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
- 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.
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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