Director, Clinical Data Management - Seattle, WA | Biospace
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Director, Clinical Data Management

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

Director, Clinical Data Management

As the Director, Clinical Data Management, you will be responsible for ensuring complete, accurate and consistent clinical data output. You’ll oversee the design, documentation, testing, and implementation of electronic clinical data systems as well as be responsible for the supervision and oversight of clinical data management activities performed by employees and external vendors.

Come Lead 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 PharmacoSurgery® 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 glomerulonephropathies; 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 the supervision and oversight of clinical data management. This will include:

•   The implementation of clinical data systems including electronic data capture (EDC), randomization and medical coding

•   Overall Medidata systems implementation, including modules used by Clinical and other departments

•   Acting as the main point of contact with vendors; overseeing budgets and contract negotiations as well as change in scope amendments for use of systems and personnel

•   Working with senior management to set global data strategy, including utilization of systems, CROs and other external resources

•   Working closely with members of clinical development, biometrics and system vendors, you’ll establish best practices for system implementation

•   Defining and gathering departmental metrics, creating standard operating procedures and generating continuous quality improvement projects

•   Developing internal as well as external training programs for clinical systems

•   Overseeing internal and external audits of clinical data systems

•   Supervising personnel and activities in clinical data management including:

o   Preparing and delivering standard clinical data management documents such as Case Report Forms (CRFs), Data Management Plans (DMP), Data Validation Plans (DVP), Data Quality Plans (DQP), SAE/AE Reconciliation Plans, CRF Completion Guidelines, and Edit Check Development and Validation

•   Manages and provides mentorship to Data Management employees including developing and evaluating personnel ensuring the efficient operation of this function

Requirements

What education and experience do you need?

You’ll need a BS degree with a minimum of 10 years of experience in clinical data management with the pharmaceutical industry. In addition, you’ll need to have:

•   Demonstrated experience in effectively prioritizing and managing multiple tasks simultaneously

•   Experience with Medidata Solutions software suite of products

•   Previous experience leading and developing a group of employees


What skills and knowledge are we seeking?

Our ideal candidate will need to have:

•   Knowledge of GCP and FDA regulatory requirements

•   Knowledge of CDISC and SAS programming is strongly preferred

•   Knowledge of core data management activities

•   Attention to detail

•   Excellent organizational ability

•   Computer knowledge

•   Excellent communication skills, both written and verbal

•   Interpersonal skills

•   Proven analytical and problem-solving skills

•   The ability to build and maintain positive relationships with management, peers, subordinates, and vendors

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.