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Senior Clinical Data Manager

Company: Kelly Services
Location: Seattle
Posted on: April 9, 2021

Job Description:

Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.OverviewThe Senior Clinical Data Manager (CDM) leads and monitors the collection, processing, data entry and quality control of study data. The incumbent is responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. The incumbent develops and maintains successful working relationships with their team to ensure and maintain data integrity and quality.Applying GCP and GCDMP principles, the Senior 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 Senior 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 Senior 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 practicesResponsibilities

  • 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. Track and manage 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
  • Lead the development of Case Report Forms (CRFs) for assigned studies
  • Be accountable for the design of the protocol/study specific database for assigned studies
  • Be accountable for 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 as 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
  • Lead development of Omeros procedures and best practices as warranted
  • Assist in the development and maintenance of standardization tools and training materials as requested
  • Participate in the interview, evaluation and qualification of CDM candidates
  • Mentor junior staff members and provide training based on specific expertiseQualifications
    • A --bachelor's degree in Life Sciences, Library Sciences or Computer Science
    • At least five years of experience as a CDM in Pharmaceutical or CRO setting
    • Proficiency in the development and use of commercial EDC products (preference given for Medidata Rave/Balance/CTMS)
    • Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) favorable
    • Proficiency in MS Office suite (incl. Word, Excel, PowerPoint)
    • Knowledge of FDA regulations/ICH/ GCP/GCDMP guidelines
    • Excellent written and verbal communication skills#TJP2021_SPECWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Seattle , Senior Clinical Data Manager, Healthcare , Seattle, Washington

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