senior Central Monitor, Data Surveillance, Clinical Data Sciences
Pf Health
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 using Risk Based Monitoring approaches
Job Summary
The Senior Central Monitor ensures the completeness, quality and integrity of subject data in clinical trial databases using Risk Based Monitoring approaches.
They develop and implement RBM systems, define key risk indicators, and collaborate with global study teams to meet study objectives.
The role requires compliance with regulations and SOPs, technical expertise in clinical data systems, and effective communication with stakeholders.
Matching Summary
The Senior Central Monitor ensures the completeness, quality and integrity of subject data in clinical trial databases using Risk Based Monitoring approaches.
Skills & Requirements
Must-have
Risk-Based Monitoring system setup
Clinical trial database management
Key Risk Indicators (KRIs) definition
Data quality assessment (DQA)
Oracle, PL/SQL, SAS technical skills
Clinical data review and signal management
Regulatory compliance and SOP adherence
Nice-to-have
Project management skills
Effective stakeholder communication
Cross-study learning facilitation
Troubleshooting database issues
Hybrid work environment
Technical expertise in clinical trials
Multi-tasking and prioritization ability
Key Requirements
Bachelor’s degree or equivalent experience
Minimum 7 years clinical development experience
Knowledge of Phase I-IV clinical trial processes
Experience in data management and database setup
Proficiency in Oracle, PL/SQL, SAS, Java
Understanding of ICH GCP and regulatory requirements