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Position: Senior Associate Central Monitor- Risk Based Monitoring
Location: Chennai, Tamil Nadu, India
- The Senior Associate, 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 a 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 Associate, 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 Associate, Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Associate, Central Monitor works with the global study team to meet the study objectives.
- 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 the RBM system at the study level to ensure system quality.
- Define key risk indicators (KRIs) in the study system, and ensure consistency between the standard level and the study level.
- Set up a dictionary for data quality assessment DQA in the study system
- Ensure the RBM system aligns 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 documentation for RBM related activities to ensure data completeness and accuracy.
- Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with the study team for the action resolution.
- Work with Clinical Data scientists to ensure all signals and actions are properly mitigated and RBM systems properly released.
- Ensure lessons learned during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.
Desired Knowledge & Skills:
- Working knowledge of the 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 the 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 Skills Required:
- 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 receive instruction primarily on unusual situations
- Ability to organize tasks, time, and priorities; ability to multi-task
- Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
- Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
Qualification: Bachelor’s degree or above or equivalent experience in a scientific or business-related discipline required.
Experience: 3 – 5 years of working experience in the clinical development fields.
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