Clinical Monitoring Oversight Strategist at Prokidney

Position Summary

The Clinical Monitoring Oversight Strategist is a strategic leader responsible for ensuring that all clinical programs executed through CRO partners meet the highest standards of quality, compliance, and inspection readiness. This role provides oversight of monitoring activities, risk‑based quality management, and regulatory preparedness across assigned programs, and plays a key role in shaping processes, governance, and quality expectations for Clinical Operations.

Key Responsibilities

Monitoring Oversight & Quality Leadership

• Leads a comprehensive monitoring oversight strategy that ensures high‑quality execution of clinical trials. This may include the development of additional tracking and monitoring enhancements tools to achieve excellence.
• Develop and implement monitoring oversight strategies, driving operational excellence, data integrity and inspection readiness across sites.
• Establish, monitor, and refine oversight frameworks, KPIs, dashboards, and governance structures to evaluate monitoring performance and site quality.
• Conduct remote reviews of monitoring outputs, site trends, quality signals, and risk indicators to proactively identify issues and drive mitigation.
• Provide expert guidance on monitoring plans, risk‑based monitoring approaches, and escalation pathways.
• Serve as an escalation point for monitoring‑related quality concerns and systemic issues.
• Partner with the internal team and the CRO on establishing site corrective and preventative actions and ensuring quick resolution of quality issues.

• Responsible for ensuring eTMFs are inspection ready
• Manage site level eTMF audits and resolution on findings
• Ensure all oversight documentation, monitoring narratives, and quality evidence are inspection‑ready at all times.

Training & Process Improvement and SOPs

• Oversee training requirements for CO
• Oversee new SOP (WI, Form, Template) creation for CO-owned SOP
• Oversee the periodic review of CO-owned QDs and cross-functional SOPs
• Drive CO review of cross-functional SOPs
• Collaborate closely with Clinical Operations, Quality Assurance, Data Management, Regulatory Affairs, and Safety to ensure integrated oversight and readiness.
• Provide strategic and operational guidance to study teams on monitoring strategy, risk management, and inspection readiness.
• Contribute to cross‑functional initiatives focused on operational excellence, process improvement, and quality culture.

Qualifications

• Bachelor’s degree in life sciences or related field required
• 12+ years of experience in clinical research, with significant expertise in monitoring oversight, clinical operations, or clinical quality.
• Deep knowledge of ICH‑GCP, global regulatory expectations, and inspection readiness best practices.
• Demonstrated success leading monitoring and CRO activities for inspection readiness efforts
• Extensive experience overseeing monitoring in a sponsor environment.
• Strong skills with the ability to interpret complex data and identify quality risks.
• Ability to thrive in a remote, fast‑paced, matrixed environment.