About the Role
This role is responsible for leading clinical monitoring oversight across multiple clinical trials, ensuring adherence to protocols, regulatory standards, and operational timelines. The individual will manage monitoring teams, support audit readiness, and drive process improvements to maintain high-quality clinical data.
Responsibilities
- Lead oversight of clinical monitoring activities for multiple trials
- Ensure monitoring practices align with protocols and regulatory requirements
- Supervise and guide clinical monitoring teams
- Conduct regular site performance evaluations
- Identify risks to data quality and implement mitigation strategies
- Collaborate with cross-functional teams to resolve site-level issues
- Review monitoring visit reports and follow-up actions
- Support inspection and audit preparedness activities
- Develop and maintain monitoring-related documentation
- Ensure compliance with SOPs, GCP, and applicable regulations
- Participate in vendor selection and management
- Monitor monitoring budget and resource utilization
- Drive continuous improvement in monitoring processes
- Train team members on monitoring standards and updates
- Coordinate with data management and safety teams
- Assist in protocol and CRF development
- Review clinical study reports for monitoring-related content
- Escalate critical site or data issues to project leadership
- Maintain oversight of third-party monitoring vendors
- Ensure timely resolution of monitoring findings
- Support central monitoring and risk-based monitoring strategies
- Track and report on monitoring metrics and KPIs
- Contribute to study start-up and close-out activities
- Review monitoring plans and monitoring strategy documents
- Ensure proper documentation in trial master files
Work Arrangement
Hybrid
Work Arrangement
This position operates in a hybrid model, combining remote and on-site work. Employees are expected to report to the designated office location on scheduled days.
