senior Central Monitor, Data Surveillance, Clinical Data Sciences
Pfizer Com Ec
Hybrid
Risk-based monitoring system setup
Clinical trial database management
Data quality assessment and control
The Senior Central Monitor ensures the completeness, quality and integrity of subject data in clinical trial databases under Risk Based Monitoring mode
Job Summary
The Senior Central Monitor ensures the completeness, quality and integrity of subject data in clinical trial databases under Risk Based Monitoring mode.
They implement global strategies and provide technical expertise to set up and test study level Risk-Based Monitoring systems while ensuring compliance with regulations and SOPs.
The role involves working with global study teams to meet objectives, managing signal and action processes, and documenting lessons learned to facilitate cross-study improvements.
Matching Summary
The Senior Central Monitor ensures the completeness, quality and integrity of subject data in clinical trial databases under Risk Based Monitoring mode.
Skills & Requirements
Must-have
Risk-Based Monitoring system setup
Clinical trial database management
Data quality assessment and control
Signal and action management
Knowledge of Oracle, PL/SQL, SAS, Java
Clinical data review and monitoring
Nice-to-have
Project management skills
Effective stakeholder communication
Cross-study learning facilitation
Troubleshooting database issues
Hybrid work environment
Key Requirements
Bachelor’s degree or equivalent experience
Minimum 7 years clinical development experience
Experience with clinical data management processes
Knowledge of clinical trial phases I-IV and study design
Experience with CRF design, database setup, and data cleaning
Technical skills in Oracle, PL/SQL, SAS, Java
Understanding of ICH GCP and regulatory requirements