Experience

SEATTLE CHILDRENS RESEARCH INSTITUTE

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Data Management Specialist

  • Feb 2020 - Present



Fred Hutchinson Cancer Research Center

• Laboratory Data Coordinator

  • Aug 2014 - Present

  Coordinating laboratory data management procedures, including data collection, processing, storage, and quality control practices.Dataset review and manipulation, across multiple platforms for laboratory data discrepancy resolution.Reviewing protocols, Laboratory SSPs, Specimen Collection Tables, and other documentation to facilitate specimen monitoringAssisting in code validation

• Lead Data Coordinator

  • May 1989 - Present

  Study database design and setup including variable style and edit check identification, study setup documentation, entry guidelines and creating visit maps according to protocol timelines and expectations.Monitoring of study data via the validation process, obtaining corrections and clarifications of study data from study sites and assisting the study team in producing datasets that support the study objectives.Maintaining the study integrity, identifying links between study objectives and data and participating in forms development and review.Acting as liasion between domestic and international research site staff for specific and global data management quality issues.Performing code validation and testing, both batch and live in test and production environment.Performing data reconciliation across multiple data pipelines, interfacing with project teams, for lab assay and CASI data.

• Clinical Data Manager

  • Dec 2015 - Feb 2020

  Manages study/project implementation including but not limited to leading SCHARP team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training.Manages assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.Resolves issues/problems using appropriate internal and/or external resources. Tracks and manages issues escalating to the appropriate level in a timely manner.Participates in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.Works with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.Acts as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.Assists in development of Case Report Forms (CRFs) for assigned studies.Assists in the design of the protocol/study specific database for assigned studies.Assists 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.Performs User Acceptance Testing (UAT) for assigned studies.Monitors study data to insure the quality and completeness of the data submitted by implementing quality control procedures.Generates QC reports for site review and correction as well as a variety of other reports as required.Evaluates study data for protocol compliance.Assists in the maintenance of documentation of the study database and other related data management programs and/or applications.Assists in the review of new and revised departmental SOPs and WPGs.Ensures that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).



Seattle Children's

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate

  • Sep 2018 - Feb 2020