senior Central Monitor, Data Surveillance, Clinical Data Sciences
pfizer.dk
Hybrid
Risk-based monitoring system development
Clinical trial database management
Key risk indicators (kris) definition
The Senior Central Monitor ensures the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring mode
Job Summary
The Senior Central Monitor ensures the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring mode.
They develop and implement Risk-Based Monitoring systems, define key risk indicators, and manage signal and action processes to support clinical studies.
The role requires collaboration with global study teams and adherence to regulatory requirements, SOPs, and corporate standards to meet study objectives.
Matching Summary
The Senior Central Monitor ensures the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring mode.
Skills & Requirements
Must-have
Risk-Based Monitoring system development
Clinical trial database management
Key risk indicators (KRIs) definition
Data quality assessment setup
Signal and action management
Clinical data review and issue resolution
Regulatory compliance and SOP adherence
Nice-to-have
Project management skills
Effective stakeholder communication
Cross-study knowledge sharing
Technical troubleshooting skills
Global study team collaboration
Multi-tasking and prioritization
Knowledge of state-of-the-art technologies
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
Technical skills in Oracle, PL/SQL, SAS, Java
Understanding of clinical trial database applications