We are seeking an experienced, high caliber Clinical Data System Analyst (CDSA II) to be responsible for various special projects related to the data systems aspects of the clinical studies conduct. These special projects will help to ensure the integrity of the processing and evaluation of clinical data. Closely collaborates with the Data Management and Systems Development groups within the Clinical Data Operations organization. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. May serve as a project manager in various projects.
- Acts as a liaison between the Clinical Data Systems users and Engineering Development group.
- Responsible for collecting design requirements and specifications for new clinical data management applications. Writes specifications for reports to be created by the Systems Development group. Interacts with appropriate departments whenever inconsistencies are found within custom build applications, reports and alerts.
- Responsible for reviewing and testing of initial study database set up. Also responsible for testing custom reports and new clinical applications.
- Provides input into how processes are designed and identifies productivity improvements within Clinical Data Operations group.
- Inform and train in-house, field and external personnel on existing components of clinical data systems such as applications, reports, dashboards which may be used to manage clinical studies. Customer-service focused.
- Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends.
- Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
- Bachelor's Degree in Computer Science, related field, or equivalent.
- Typically a minimum of four plus years’ experience in a health care industry; experience to include a thorough understanding of data management processes.
- General knowledge of database terminology and technology, knowledge of basic Structured Query Language (SQL) and demonstrated ability to generate queries.
- Demonstrated familiarity with MS Office, especially Word, Excel, and Access.
- Demonstrated oral and written interpersonal, communication, analytical, presentation, and organizational skills; the ability to meet deadlines/work independently. Must be adept at handling multiple assignments in a timely manner and meeting assigned deadlines.
- Must have the demonstrated ability to understand and comply with applicable U. S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks.
- Evaluation, originality and/or ingenuity required.