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Clinical Data Manager

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Aug 3, 2022

View more

Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioForest
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Job Details

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 join our Omeros Clinical Team!

 

Who is Omeros? 

 

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

 

What are your job 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
  • 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 ensure 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

 

Education, Skills and Knowledge

 

  • 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 trial 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
  • Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors
  • Ability to develop and present varied and unique ideas

 

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
  • 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

 

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

 

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Find Us
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
98119
US
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