Sr. Clinical Database Analyst

Clinical St. Paul, Minnesota


Description

Position Responsibilities:

General Requirements

  • Lead or participate in regular Clinical Information Systems (CIS) team meetings and study team meetings
  • Gather and document requirements for new clinical information system features and reports
  • Manage required regulatory documentation in regards to study data compliance, as directed
  • Maintain knowledge of clinical information systems sufficient to schedule and train internal and site personnel on use of clinical information systems
  • Collaborate with the study team to facilitate knowledge transfer across projects
  • Perform all activities under the requirements of CSI SOPs
  • May serve as the subject matter expert for one or more CSI SOPs
  • May lead or support CAPAs or process improvement efforts

 

Process Improvements for Clinical Information Systems

  • Facilitate and contribute to the development of data management plans
  • Assist in review of clinical study protocols for database review requirements
  • Contribute to the development of CRFs for clinical data collection against the protocol and database standardization efforts
  • Identify process improvements for clinical information system activities to reduce time to clean data and increase data accuracy
  • Design and implement new system validation, report testing, and feature testing processes as required for feature additions
  • Assist with developing materials and reviewing output for mandatory study reporting (e.g. DMC, CEC, and other mandated regulatory reporting to government agencies)

Development of Clinical Study Databases

  • Primary responsibility includes:
    • Lead testing and validation efforts for the clinical study database, study reports, and any features developed by the CIS team
    • Manage new user requests and assign new users to the existing study models
    • Develop basic reports under provided templates for study-level data reporting
  • Develop data entry screens for collection of clinical data in accordance to the protocol and CRFs
  • Develop programmatic edit checks to assist with automated query generation
  • Activate built-in database features to assist with the management of the clinical trial
  • Develop advanced database features (e.g. visit skip logic, advanced edit checks, monitoring functionality)
  • Other database development activities as assigned

Administration of Clinical Information Systems

  • Manage system security to ensure data integrity and compliance with governing policies and procedures
  • Collect and analyze system requirements for development activities and provide input to the clinical team on feature availability, new feature design, and potential design challenges prior to development activities commence
  • Collect requirements, interpret, design, and develop custom study-level reports for clinical trials
  • Configure and define existing Clinical Trial Management System (CTMS) functionality to assist the study team in managing non CRF clinical trial data
  • Design new system validation, report testing, and feature testing processes as required for feature additions

 

Knowledge, Skills and Abilities Required for Successful Job Performance:

  • Bachelor’s degree in life sciences, physical sciences, statistics, computer science, or other related field
  • A minimum of six (6) years professional experience in clinical database development or clinical data management in medical device or drug clinical trial operations
  • Detailed understanding of good clinical practices, good data management processes, clinical research, clinical trial process, and related regulatory requirements and terminology
  • Experience with clinical trials that use Electronic Data Capture (EDC)
  • Experience with Structured Query Language (SQL), design of user interface for data collection, and database architecture
  • Experience mentoring/training on advanced database development techniques
  • Excellent organizational skills and strong attention to detail
  • Established:
    • interpersonal and communication skills necessary to interact cross functionally and outside of CSI
    • experience with developing test scripts for application and/or report testing
    • ability to translate regulations and guidelines into daily practice to shape process and inform decisions
    • ability to coordinate multiple tasks and reprioritize based on changing demands to meet study timelines
    • proficiency in Microsoft Office software- Word, Excel, Power Point
  • Preferred
    • understanding of Good Clinical Data Management processes
    • ability to influence direction and decision making

 

Specifications/Other:

  • Ability to work in front of a computer for up to 8 hours a day
  • Physical Abilities: must be able to lift 20 lbs
  • Working Conditions:
    • We are a fast growing company with lots of opportunities for growth.
    • Travel up to 10%

CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. 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.