Director, Clinical Data Management

Director, Clinical Data Management

The Director, Clinical Data Management will be responsible for day-to-day data management tasks for all studies conducted by Omeros Corporation and collaborate with other functional areas such as clinical development, clinical operations, statistical programming, and biostatistics. This person will ensure the accuracy, consistency, completeness, and high quality of the clinical database. In addition, the incumbent will be responsible for the overall development, management, and administration of Data Management function at Omeros Corporation. The Director, Data Management will report to the VP, Biostatistics, Data Management and Programming and will work closely with cross-functional teams on multiple clinical development programs.

Good things are happening at Omeros!

Come join our Omeros Clinical 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 and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

• Implementation of clinical data systems to include, but not limited to, electronic data capture (EDC) and medical coding
• Overall Medidata systems implementation, including modules used by Clinical and other departments
• Acting as a main point of contact with vendor(s); overseeing budgets and contract negotiations, as well as change in scope amendments for use of systems
• 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 to 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, as well as external audits of clinical data systems
• Supervising personnel and activities in clinical data management including:
  • Preparing and delivering standard clinical data management documents such as Data Management Plans (DMP), Data Validation Plans (DVP), Data Quality Plans (SQP), SAE/AE Reconciliation Plans, External Vendor Reconciliation Plans (e.g. labs), Data Entry Guidelines and Edit Check Development and Validation
• Leading and providing mentorship to Data Management employees including developing and evaluating personnel ensuring the efficient operation of this function

Education, Experience, Skills, and Knowledge Required:

• BS degree with a minimum of 10 years of experience in clinical data management with the pharmaceutical industry or a related industry with a proven track record
• Strategic leadership in a cross-functional team setting, EDC databases, CDASH, medical terminology, medical coding dictionaries, and quality control processes.
• Demonstrated experience in effectively prioritizing and managing multiple tasks simultaneously
• Previous experience successfully leading and developing a group of employees
• Knowledge of GCP and FDA regulatory requirements
• Knowledge of CDISC and SAS programming strongly preferred
• Computer knowledge and experience with Medidata Solutions Electronic Data Capture (EDC) software
• Knowledge of core data management activities
• Excellent written and verbal communication skills
• Proven analytical and problem-solving skills, along with an excellent organizational ability
• Strong interpersonal skills

Behavioral Competencies Required:

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

Physical Demands Required:

• May encounter prolonged periods of sitting

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