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
•    Execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study. 
•    Provide technical support to resolve conflicts, influence and communicate with key stakeholders and customers.

System setup Functions:
•    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.
•    Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data review Functions:
•    Provide technical support to define the issue resolution for the reviewing findings as signal and action. 
•    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.   

  

  
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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