Sr. Clinical Database Developer

Company: Cardiovascular Systems, Inc
Location: Saint Paul
Posted on: March 18, 2023

Job Description:

Putting a new spin on your careerWorking at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don't simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!Job Description:Job Summary:This role is responsible for building and maintaining clinical trial databases and related components across the portfolio of CSI clinical trials. This role ensures that development activities are conducted in compliance with regulatory guidelines, policies, and internal procedures. This role collects and documents the requirements to build the database and operational tools as needed. This role works closely with trial teams and other clinical partners to establish comprehensive and connected processes throughout the trial lifecycle.Essential Duties and Responsibilities:

• Builds clinical trial databases and related components
• Collaborates on the development of CRFs to support database build and standardization efforts
• Collects, analyzes, and documents database requirements and provides consulting and training to the team on feature availability, design challenges and potential risks
• Configures Clinical Trial Management System (CTMS) and other system functionality to assist the team in managing non-CRF clinical trial data
• Programs edit checks and other database tools and reports to assist with data quality management
• Provides technical input on data management plans and other CDM documentation
• Collaborates on the validation of the clinical trial database and related components, and operational trial reports
• Manages system user activation and removal requests
• Defines and documents trial-level database security in partnership with trial team
• Maintains expert knowledge of data management systems to train and support trial personnel
• Collects requirements, interprets, designs, and develops trial reports
• Supports CAPAs as needed
• Provides input to clinical trial protocols for database configuration requirements
• Serves as the subject matter expert for one or more CSI Standard Operating Procedures
• Participates in system upgrades to ensure adequate testing of new and/or modified features
• Manages development deliverables to meet overall trial timelines and objectivesQualifications:Required
  • BA/BS degree in STEM field, or equivalent combination of education and related experience
  • 6 years professional experience in clinical database development experience OR Master's degree and 4 years related experience
  • Demonstrated application of Good Clinical Practices (GCP), data management best practices, and regulatory requirements in the execution of clinical trial operations
  • Proficient in Microsoft Office software - Word, Excel, Power Point
  • Experience configuring Electronic Data Capture (EDC) systems for data collection (e.g. Clindex, Rave, Medidata, Oracle, IBM EDC, etc)
  • Extensive knowledge of applicable CFR (including part 11) and ISO requirements as well as governing procedures, policies, and regulationsPreferred:
    • Experience working on FDA regulated clinical trials
    • Knowledge of Structured Query Language (SQL)Specifications/Other:
      • Must be able to lift 25 lbs
      • Work is performed on-site in an office environment with exposure to electrical office equipment.
      • Must be able to look at a computer screen for up to 8 hours per dayCSI is an EEO/AA company: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600

Keywords: Cardiovascular Systems, Inc, St. Paul , Sr. Clinical Database Developer, IT / Software / Systems , Saint Paul, Minnesota