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JOB SUMMARY:

• Performs data management activities for both clinical studies and development projects as assigned.
• Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission.
• Supports all data-related activities including data entry, verification and scribing when needed.
• Supports Lead Data Managers in execution of assigned tasks.
• Assists and contributes to the compilation of all data management documentation for assigned projects. Reviews and adheres to the requirements of study-specific DMP.
• Prepares and enters test data for user testing of clinical database and edit checks.
• Participates in study-specific data entry training and serves as backup to data entry staff.
• Performs basic clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data.
• Generates discrepancies and updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.
• Assists in preparation of relevant subject data files and study documentation for audits and quality control.
• Performs other duties as assigned.
• Other duties as assigned by management.

QUALIFICATIONS:

• Bachelor’s Degree
• Years of Experience – Entry Level
• Ability to work with relevant computer software, including spreadsheets, word-processing and database packages (e.g., Microsoft Excel, Word and Access).
• Excellent communication and interpersonal skills.
• Ability to work under time pressure while maintaining high standards of precision and data quality