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Clinical Database Specialist
3 weeks ago
This critical role involves developing and maintaining clinical databases for multiple trials, ensuring compliance with global regulatory requirements and business objectives. A successful candidate will have a deep understanding of data management processes, data governance, and data quality.
Main Responsibilities:
- Design and implement clinical databases for assigned trials, incorporating best practices for data management and quality control.
- Collaborate with cross-functional teams to develop and maintain process deliverables, ensuring consistency across assigned trials with program-level standards.
- Perform ongoing review of all data generated from the clinical study, identifying areas for improvement and implementing corrective actions as needed.
- Provide regular status reports to clinical trial teams and support junior staff members on assigned trials.
- Liaise with study teams, functional lines, and external partners to ensure timely and high-quality deliverables.
Key Performance Indicators:
- Achieve high levels of quality, timeliness, cost efficiency, and customer satisfaction across Data Management activities and deliverables.
- No critical audit findings due to Data Management.
- Adherence to established policies and guidelines.
Requirements:
- Cross-cultural experience.
- Functional breadth.
- Project management.
- Clinical data management.
- Data governance.
- Data integrity.
- Data management.
- Data quality.
- Data science.
- Databases.
Skills Desired:
- Clinical data management.
- Databases.
- Data governance.
- Data integrity.
- Data management.
- Data quality.
- Data science.
- Waterfall model.
Language: English