湖北省-武汉市 | 若干人
• Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode.
• Areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution.
• Ensure risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times.
• Familiar with supported systems (RBM system, etc) and able to troubleshoot and provide rapid response for all database issues.
• Work with the global study team to meet the study objectives.
• Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
• Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
• Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
• Knowledge of clinical trial database and its applications
• Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.