Accountabilities: Demonstrates competence while performing a limited number of activities including:

• User Acceptance Testing
• Data validation and cleaning
• Generation and integration of data queries
• Data reconciliation tasks
• Identifying and reporting protocol deviations
• Support site monitoring personnel to retrieve missing data as required
• Provide work status updates regularly to direct supervisor
• Other assigned responsibilities as needed

Skills

• Good interpersonal, verbal and written communication skills
• Awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
• Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
• Ability to work in team environment
• Good analytical skills and attention to detail
• Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner Education

Qualifications

• Bachelor’s degree and / or other medical qualification or relevant DM experience Language Skills
• Competent in written and oral English. Excellence in regional languages as needed. Minimum Work Experience
• Previous relevant data management work experience required; clinical and/ or research experience required