- Working under general supervision, is responsible for all aspects of data management activities in support of assigned clinical studies.
- These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.
- Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed.
- 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.
- Ensures that quality of services meets internal and external customer requirements.
- Performs all data management activities for assigned studies, as appropriate
- Protocol and Statistical Analysis Plan (SAP) review and input
- Case Report Form (CRF) development and maintenance
- Edit Check specifications development and maintenance
- Data Management Plan development and maintenance
- Data Quality Checks and discrepancy management
- Analyzes data, identifies trends; prepares data tables for reports
- Database setup testing and Edit Check programming testing
- Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent.
- Typically a minimum of four plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes.
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