senior Central Monitor, Data Surveillance, Clinical Data Sciences
pfizer.de
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 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 provide technical expertise to set up and test study level Risk-Based Monitoring systems and ensure compliance with regulations and SOPs.
The role involves working with global study teams to meet study objectives and implementing quality oversight steps in central monitoring activities.
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 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 in clinical trials
Nice-to-have
Project management skills
Effective stakeholder communication
Cross-study knowledge sharing
Troubleshooting database issues
Technical expertise in clinical data systems
Ability to multi-task and organize priorities
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
Proficiency in Oracle, PL/SQL, SAS, Java
Understanding of clinical trial database applications