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Clinical Data Analyst
4 weeks ago
Contract
Sylmar, California, US

Job Description

  • 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.

 

Job Duties:

  • 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

 

General Qualifications:

  • 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.

Job Requirements

Clinical Data, Clinical Data Manager, Clinical Data Management System, Clinical Research, FDA , CRF , ICh, Pharma, Medical Device, Pharmaceutical

 

Job Code: 50066473

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