senior Central Monitor, Data Surveillance, Clinical Data Sciences
pfizer.hu
Hybrid
Risk-based monitoring system setup
Clinical trial database management
Key risk indicators (kris) definition
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, ensuring compliance with regulations and SOPs.
The role involves working closely with global study teams to meet study objectives 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
Key Risk Indicators (KRIs) definition
Signal and action management
Data quality assessment dictionary setup
Oracle, PL/SQL, SAS, Java skills
Clinical data review and monitoring
Nice-to-have
Project management skills
Effective verbal and written communication
Ability to resolve conflicts and influence stakeholders
Cross-study learning and documentation
Hybrid work environment
Key Requirements
Bachelor’s degree or equivalent experience
Minimum 7 years clinical development experience
Knowledge of clinical development phases I-IV
Experience in data management roles
Understanding of CRF design and database setup
Familiarity with clinical trial database applications