ROLE SUMMARY
The Senior Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The 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. The Senior Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Central Monitor works with the global study team to meet the study objectives.
ROLE RESPONSIBILITIES
General:
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Provide technical expertise to set up and test study level Risk-based Monitoring system
- Review study level system outputs to process for the signal and action management
- Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
- Able to resolve conflicts, influence and communicate with key stakeholders and customers.
- Implement quality oversight/control steps implemented in the central monitor activities.
System setup Functions:
- Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.
- Provide technical oversight, guidance and coordination for all the central monitor activities.
- Set up and test RBM system at study level to ensure system quality.
- Define key risk indicators (KRIs) in study system and ensure consistency between the standard level and the study level.
- Set up dictionary for data quality assessment DQA in study system
- Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.
Data review Functions:
- Work with Study Team to define the issue resolution for the reviewing findings as signal and action.
- Develop, implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.
- Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.
- Work with Clinical Data Scientist (CDS) to ensure all signal and actions are properly mitigated and RBM systems properly released.
- Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.
BASIC QUALIFICATIONS:
- Bachelor’s degree or above of equivalent experience in a scientific or business-related discipline required.
- Minimum 7 years of relevant working experience in the clinical development field.
- 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.
Technical Skill Requirements:
- Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
- Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
- Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- Works independently, receives instruction primarily on unusual situations
- Ability to organize tasks, time and priorities; ability to multi-task
- Ability to communicate effectively and appropriately with internal &
Work Location Assignment: Hybrid
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