Monitoring Services Oversight Manager (Remote)
Novartis
August 15, 2026
Remote
United States
Clinical Research and Development
Key Responsibilities:
- Serve as the primary liaison for monitoring service vendors and functional service provider partners.
- Establish governance models to promote high-quality vendor performance and operational excellence.
- Align resource strategies with vendor leadership to support study and trial delivery needs.
- Monitor site activation, enrollment, data flow, and timeline commitments across clinical studies.
- Oversee monitoring resourcing, training, quality, timely data entry, and resolution of study-related issues.
- Drive performance management through key performance and quality indicator oversight.
- Escalate compliance concerns, performance gaps, and capability needs to vendor leadership.
- Support audit readiness, inspections, and corrective actions across vendor-managed activities.
- Partner with Clinical Project Managers to strengthen site recruitment and monitoring effectiveness.
- Identify performance trends and support targeted development initiatives to improve monitoring quality.
Essential Requirements:
- Bachelor’s degree in life sciences, healthcare, or a related scientific discipline.
- Significant experience in clinical research, clinical operations, or monitoring oversight.
- Strong knowledge of Good Clinical Practice, regulatory requirements, and clinical trial conduct.
- Experience managing functional service provider or vendor relationships within clinical development.
- Demonstrated ability to influence internal and external stakeholders without direct authority.
- Strong understanding of clinical monitoring, site performance, and data quality metrics.
- Proven ability to identify risks, resolve performance issues, and drive continuous improvement.
- Excellent communication, collaboration, and organizational skills in complex global environments.
Desirable Requirements:
- Experience supporting global or regional clinical trial portfolios across multiple countries and stakeholders.
- Previous involvement in audit preparedness, regulatory inspections, or vendor governance programs within clinical development.
- Serve as the primary liaison for monitoring service vendors and functional service provider partners.
- Establish governance models to promote high-quality vendor performance and operational excellence.
- Align resource strategies with vendor leadership to support study and trial delivery needs.
- Monitor site activation, enrollment, data flow, and timeline commitments across clinical studies.
- Oversee monitoring resourcing, training, quality, timely data entry, and resolution of study-related issues.
- Drive performance management through key performance and quality indicator oversight.
- Escalate compliance concerns, performance gaps, and capability needs to vendor leadership.
- Support audit readiness, inspections, and corrective actions across vendor-managed activities.
- Partner with Clinical Project Managers to strengthen site recruitment and monitoring effectiveness.
- Identify performance trends and support targeted development initiatives to improve monitoring quality.
Essential Requirements:
- Bachelor’s degree in life sciences, healthcare, or a related scientific discipline.
- Significant experience in clinical research, clinical operations, or monitoring oversight.
- Strong knowledge of Good Clinical Practice, regulatory requirements, and clinical trial conduct.
- Experience managing functional service provider or vendor relationships within clinical development.
- Demonstrated ability to influence internal and external stakeholders without direct authority.
- Strong understanding of clinical monitoring, site performance, and data quality metrics.
- Proven ability to identify risks, resolve performance issues, and drive continuous improvement.
- Excellent communication, collaboration, and organizational skills in complex global environments.
Desirable Requirements:
- Experience supporting global or regional clinical trial portfolios across multiple countries and stakeholders.
- Previous involvement in audit preparedness, regulatory inspections, or vendor governance programs within clinical development.