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Senior Associate, Central Monitor
3 semanas atrás
**JOB SUMMARY**
**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 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.
**QUALIFICATIONS**:
- Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
- 3 - 5 years working experience in the clinical development fields.
- 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
- 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 & 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.
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