Clinical Data Associate - Seattle, WA | Biospace
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Clinical Data Associate

Omeros Corporation

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Location:
Seattle, WA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Clinical Data Management, Pharmaceutical,

Job Description

Clinical Data Associate

These are exciting times at Omeros with a promising pipeline and future! Our Clinical group is looking for an experienced Clinical Data Associate to join their team.   This is a regular full-time position where you will have the ability to make an impact immediately.

Come Be A Part Of Our Clinical Data Team!

Who is Omeros?

Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.
Part of its proprietary Chemosurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephritis’s; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.

What will your responsibilities be?

In this role, you will be responsible for supporting the data management study team leads in data cleaning and database testing activities on studies, assisting in ensuring complete, accurate and consistent clinical data output.

Your responsibilities in this role include:

•   Working with the data management study team leads, cleaning clinical study databases utilizing Omeros’ electronic data capture system. This includes:

o   Query processing including query generation and resolution

o   Adverse events reconciliation of safety database with EDC database

o   Reconciliation of laboratory data with EDC database

•   Providing support to study teams

Requirements

What does our ideal candidate look like?

Our ideal candidate will have a BS degree with a minimum of 1 year of experience in Clinical Data Management in the pharmaceutical industry or in a related industry.
Along with a proven track record and your knowledge of GCP (Good Clinical Practice) standards and FDA regulatory requirements, you have the following skills:

•   A detail orientation

•   Demonstrated experience in effectively prioritizing and managing multiple tasks simultaneously

•   Excellent organizational ability

•   Excellent written and verbal communication skills

•   Analytical and problem-solving skills

•   The ability to build and maintain positive relationships with peers, management and/or others.

•   The ability to work independently while communicating resourcing issues to management


Additionally, we are seeking the following knowledge and experience:

•   Knowledge of GCP and FDA regulatory requirements

•    Computer knowledge and experience with Medidata Solutions Electronic Data Capture (EDC) software

•    Knowledge of CDISC and SAS programming will be considered a plus.

If have the talent to effectively prioritize and manage multiple tasks simultaneously, excellent verbal and written communication skills along with the skills and knowledge we are looking for, we’d like to hear from you.

All interested applicants should apply at:  Omeros.com, About Omeros, Careers.  This will route you to our online applicant tracking system.

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.