Clinical Data Manager

Location
Seattle
Posted
Jan 06, 2021
Ref
1803
Discipline
Clinical, Clinical Data
Hotbed
BioForest
Required Education
Masters Degree/MBA
Position Type
Full time
Clinical Data Manager

Good things are happening at Omeros!

Come be a part of our 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?

The Clinical Data Manager 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. They develop and maintain successful working relationships with their team to ensure and maintain data integrity and quality.

Applying GCP and GCDMP principles, the Clinical Data Manager 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 Clinical Data Manager is also expected to manage basic science questions/queries, clinical development tasks associated to the management of trial data, and internal Omeros projects. The Clinical Data Manager 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.

Essential Duties & Responsibilities:

  • 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
  • Participate in development of protocols/studies 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
  • Lead the development of Case Report Forms (CRF's) for assigned studies
  • Lead the design of the protocol/study specific database for assigned studies to include specification of edit check programs
  • Manage the maintenance of the study database to include routine revisions or additions to 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 or to support others as an SME
  • Implement quality control procedures per protocol and GCP to ensure data integrity and quality
  • Monitor ongoing study data to ensure the quality and completeness of the data submitted
  • Generate QC reports and listings for clinical and site review and correction
  • Evaluate study data for protocol compliance
  • Maintain the documentation of the study database and other related data management programs, applications and/or applied processes
  • Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)
  • Complete studies/projects ensuring completeness, documentation and storage
  • Participate in the development of Omeros procedures and best practices as warranted
  • Participate in the development and maintenance of standardization tools and training materials as requested
What experience and education do you need?

Following are the Requirements for this position:

  1. Master's Degree in Biology or Biostatistics, or a closely related life sciences field; and,
  2. Three years of experience as a Clinical Data Manager in the pharmaceutical industry,
    1. Using SAS clinical programming and EDC programming
    2. Using Medidata RAVE, Microsoft Access and Oracle Clinical RDC
    3. Developing Case Report Forms for clinical studies
    4. Developing reports using BusinessObjects
    5. Developing and using iMedidata RTSM and Coder
    6. Providing data review using validated listings and patient profiles in clinical studies
    7. Developing data review plans
    8. Reviewing or writing SOPs
    9. Managing clinical data management activities for protocols or studies applying relevant FDA regulations and ICH, GCP and GCDMP guidelines
In lieu of MS and three years of experience, will accept a BS and five years of experience, as described above. Any suitable combination of education, training, or experience is acceptable.

Other things you'll need to know:

Location of Employment: Full time / 40 hours/week at Omeros Corporation in Seattle, WA

If you have the skills, knowledge and experience we are looking for and would like to join a growing and exciting organization where you will have the opportunity to play an integral role, 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.