Pr. Clinical Database Analyst

Clinical St. Paul, Minnesota


Description

 

Job Summary:
The
Principal Clinical Database Analyst (Pr. DBA) is responsible for leading the development of clinical information systems, reports, procedures and other tools across the portfolio of CSI clinical trials. Other responsibilities include identifying and supporting process improvements related to the management of clinical information systems, leading and/or completing system testing and validation and contributing to study team deliverables, such as protocols, case report forms and plans. The Pr. DBA will be responsible for leading broad and complex projects while directing deliverables to ensure successful deployment.  This role works under general supervision and in accordance with applicable regulatory requirements and company policies.

Position Responsibilities:

1)      General Requirements

a)      Lead or participate in regular Clinical Information Systems (CIS) team meetings and study team meetings

b)      Responsible for creating and maintaining technical documentation to support clinical information systems

c)      Maintain expert knowledge of clinical information systems sufficient to schedule and train internal and site personnel on use of clinical information systems

d)      Collaborate with the study team to facilitate knowledge transfer across projects

e)      Gather, document, and implement requirements for new clinical information system features and reports

f)       Serve as the subject matter expert for one or more CSI SOPs

g)      Lead and support CAPAs and process improvement efforts

h)      Mentor other database analysts in the development and use of the clinical database software

2)      Process Improvements for Clinical Information Systems

a)      Review and provide technical input to the development of data management plans

b)      Assist in review of clinical study protocols for database review requirements

c)      Contribute to the development of Case Report Forms (CRFs) for clinical data collection against the protocol and database standardization efforts

d)      Identify and deliver process improvements for clinical information system activities to increase data accuracy and reduce time for data cleaning efforts

e)      Design and implement new system validation including testing and documentation

f)       Assist with developing materials and reviewing output for mandatory study reporting (e.g. Data Monitoring Committee, Clinical Events Committee, and other mandated regulatory reporting for government agencies)

3)      Development of Clinical Study Databases

a)      Primary responsibility includes:

i)        Develop data entry screens independently for collection of clinical data in accordance to the protocol and CRFs

ii)      Develop programmatic edit checks to assist with automated query generation

iii)    Activate built-in database features to assist with the management of the clinical trial

iv)    Manage new user requests and assigns new users to the existing study models

v)      Develop reports of varying complexity for study-level data reporting

vi)    Develop advanced database features (e.g. visit skip logic, advanced edit checks, monitoring functionality)

b)      Assist in testing and validating the clinical study database, study reports, and any features developed by the CIS team

c)      Other database development activities as assigned

4)      Administration of Clinical Information Systems

a)      Manage system security to ensure data integrity and compliance with governing policies and procedures

b)      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 commencing

c)      Work collaboratively to gather requirements, interpret, design, and develop reports and features

d)      Configure and define existing Clinical Trial Management System (CTMS) functionality to assist the study team in managing non CRF clinical trial data

e)      Lead system upgrade process to ensure adequate testing of new and/or modified features

 

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 ten (10) 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, clinical research, clinical trial process, and related regulatory requirements and terminology
  • Experience mentoring/training on advanced database development techniques
  • Excellent organizational skills and strong attention to detail
  • Experience with clinical trials that use Electronic Data Capture (EDC)
  • Established:
    • experience with developing test scripts for application and/or report testing
    • experience with Structured Query Language (SQL), design of user interface for data collection, and database architecture
    • interpersonal and communication skills necessary to interact with cross functionally and outside of CSI
    • 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:
    • experience with Fortress Medical Clindex software
    • understanding of Good Clinical Data Management processes
    • previous leadership experience
    • 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.