Clinical Data Manager

The Clinical Data Manager (CDM) leads and monitors the collection, processing, data entry, and quality control of study data. They are responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. She/he develops and maintains successful working relationships with their team to ensure and maintain data integrity and quality.

Applying GCP and GCDMP principles, the CDM manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle.

The position of the CDM is also expected to manage basic science questions/queries, clinical development tasks associated to the management of trial data, and internal Omeros projects. The CDM adheres to Omeros Standard Operating Procedures (SOPs), work practices, applicable clinical trial regulations, and study confidentiality requirements and functions with limited supervision in operational and technical matters within defined procedures and practices.

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 disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 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?

Your responsibilities in this position will include:

• Manage study/project implementation including but not limited to leading Omeros team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training

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

• Ensure rapid resolution of issues/conflicts using appropriate internal and/or external resources, tracking and managing the escalation of issues to ensure appropriate resolution in a timely manner

• Participate in development of a protocol/study from draft status to optimize the collection of accurate and high-quality data

• Work with project sponsors, stakeholders and cross-functional team members to define project requirements, scope, risks, organization, and approach

• Act as subject matter expert for data management issues between study team staff and external domestic and international research sites for assigned studies

• Assist in the development of Case Report Forms (CRF's) for assigned studies

• Collaborate in the design of the protocol/study specific database for assigned studies

• Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies

• Perform User Acceptance Testing (UAT) for assigned studies

• Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures

• Generate QC reports for site review and correction as well as a variety of other reports required

• Evaluate study data for protocol compliance

• Maintain the documentation of the study database and other related data management programs and/or applications

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

• Complete studies/projects ensuring completeness, documentation and storage

• Assist in the development of Omeros procedures and best practices as warranted

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

What education, experience, and knowledge do you need?

• Requires a university degree, BA/BS, ideally with a degree in a Life Science, Library Sciences or Computer Science

• 3+ years of experience as a CDM in a pharmaceutical or CRO setting

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

• Proficiency in the development and use of commercial EDC products, preferably Medidata RAVE/Balance/CTMS

• Proficiency in MS Office Suite (including Word, Excel, PowerPoint)

• Knowledge of FDA regulations and ICH, GCP and GCDMP guidelines

• Excellent verbal and written communication skills

• Excellent interpersonal skills

• Excellent project management and organizational skills in a clinical trials setting

Behavioral Competencies Required:

• Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors

• Demonstrated ability to develop and present varied and unique ideas

• Ability to display strong analytical and problem-solving skills

• Detail orientation required

Other Requirements:

• Possible travel, including overnight and international travel based on organizational and/or protocol specific need

Physical Demands Required:

• May encounter prolonged periods of sitting

• May frequently be performing repetitive movements such as typing on a keypad or using a mouse

• May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch

• On occasion, may lift and/or move up to 20 pounds

If you have the skills, knowledge and experience we are seeking, 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.