Lab Data Manager

The Lab Data Manager will work independently and in a team environment supporting the definition, development and collection of external laboratory data with internal staff and external collaborators/vendors with the goal of ensuring the quality and integrity of lab specimen data.

Good things are happening at Omeros!

Come work with our Clinical Data Management Team!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and diso

The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. 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. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

• Manage inbound data transfer sources from external laboratories

• Work closely with vendors, clinical operations and programming to ensure data format, quality, and provision are according to specification

• Act as a liaison to the external labs to ensure accurate content definition, design and timely processing of study results

• Lead activities with external laboratories to investigate and resolve data and reporting discrepancies

• Collaborate with the clinical operations, data management and programming teams to identify and correct defeciancies in data and reporting

• Participate in and/or lead projects that support development or improvement of processes described

• Adhere to quality policies and procedures for the management of laboratory databases and data

• Effectively manage assigned protocol/study tasks to established timelines and milestones projections in conjunction with department management, and monitor and communicate ongoing status and progress

• Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)

• Contribute to ongoing development of Omeros procedures and practices by participating in committees and working groups as requested

• Assist in the development and maintenance of standardization tools and training materials as requested

• Effectively manage assigned protocol/study tasks to established timelines and milestones projections in conjunction with department management, and monitor and communicate ongoing status and progress

• Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)

• Contribute to ongoing development of Omeros procedures and practices by participating in committees and working groups as requested

• Assist in the development and maintenance of standardization tools and training materials as requested

• Perform other duties as appropriate based on specific documented training

• Minimum Bachelor's degree in Life Sciences or similar degree or direct role experience meeting minimum requirements

• At least 3 years of clinical or lab data management experience

• Experience in the use of commercial EDC products (preference given for Medidata Rave)

• Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) favorable

• Proficiency in MS Office suite (incl. Word, Excel, PowerPoint)

• Knowledge of FDA regulations/ICH/ GCP/GCDMP guidelines

• Excellent written and verbal communication skills

• Excellent interpersonal skills

• Time management and organizational skills in clinical trials setting

• Ability to build and maintain positive relationships with management, peers, and vendors

• Detail orientated

• May encounter prolonged period of sitting

• The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse

• The employee may climb bend, reach, push, pull, balance, stoop, kneel, or crouch

• The employee must on occasion lift and/or move up to 20 pounds

If you have the skills, knowledge and experience we are looking for, we'd love to hear from you!

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.