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工作職責(zé): 1. Perform Quality Control on registry data attributes. - Utilize the source documents and data from various systems to validate the registry data attributes against Registry Data Quality Control specifications. - Identify and investigate any potential discrepancies. - Liaise with the study team Point of Contact to resolve any verified quality issues. - Maintains their study and site assignments - Creates and maintain Quality Control Workbooks - Coordinates quality control activities with other Registry Quality Management Associates as applicable ？ 2. Perform Registry Data entry in Clinical Trial Management System (CTMS) with adherence to Data Entry Process. - Create, modify or delete data attributes in the Clinical Trial Management System (CTMS) according to Registry Data Entry specifications. - Liaise with the Study Team Point of Contact to resolve registry related discrepancies and issues. ？ 3. Assist in the remediation of any incomplete or inaccurate registry data. ？ 4. Perform acquisition and divestiture related activities as they apply to Registry data and systems. ？ 5. Support data quality associated to registry systems. ？ 6. Assist in the generation of Registry reports and metrics.？ 7. Communicate, escalate issues to the Registry Quality Management Associate Lead, Registry Quality Management Lead, Registry Process Lead and Business Process Owner. ？ 8. Contribute to additional projects that may arise. ？ 9. Contribute to the process implementation management and/or process improvement activities when needed. Education: ？ Minimum of Bachelor’s degree or equivalent required. Preferred Prior Experience: ？ Experience with electronic data management system. ？ Experience with Clinical Trial Management Systems. ？ Experience in management of medical/clinical study data and documentation. ？ Experience in project management. ？ Experience in multinational working environment. ？ Knowledge of drug development and/or clinical trial. ？ History of achievement in a customer service role with demonstration of meeting customer needs. 任職資格: Competencies: ？ 1. Clinical Development Process: Good knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design ？ 2. Clinical Trial Management System Expertise: - Extensive knowledge of clinical development process, including in depth knowledge and understanding of the principles of GCP. - Extensive knowledge of Clinical Trial Management Systems and data requirements. - Good understanding of the Registry and its components. ？ 3. Computer savvy with widely used systems (e.g. Microsoft Office). ？ 4. Organizational Skills: - Ability to work independently - Ability to organize tasks, time, and priorities - Ability to multi-task ？ 5. Administrative Excellence: Attention to detail evident in a disciplined approach to data maintenance and management. ？ 6. Communication Skills: Good verbal and written communication skills demonstrated to communicate with internal/external stakeholders 7. Clinical/Scientific Aptitude: Understanding of scientific/clinical principles, knowledge of clinical trial life cycle and ability to work across different therapeutic areas. ？ 8. Decision Making: - Ability to understand the sources of various data points, and how to mine that information for meaningful data. - Ability to make routine decisions based on processes/guidance. ？ 9. Problem Solving: Ability to proactively identify and address issues.