Senior Director, Clinical Field Monitoring and Trial Operations

Position Overview

The Senior Director, Clinical Field Monitoring and Trial Operations (FMTO) provides strategic and operational leadership for Immunome’s clinical trial monitoring function, accountable for implementing Immunome’s contract field monitoring team and standardizing monitoring strategy, oversight activities, KPIs, and dashboards across all trials and monitoring vendors to ensure site-level data quality, patient safety, and protocol compliance across Immunome’s oncology portfolio.   

The Senior Director will lead and develop a high-performing field monitoring function, including a contract field monitoring team, partnering closely with Clinical Site and Trial Operations, Clinical Project Delivery Data Management, Clinical Development Systems, and Quality to ensure monitoring and TMF data, technology, and reporting enable enterprise-wide visibility into trial, site, and document performance.   

The Senior Director may also take on management and development of other trial operations staff or teams to support expansion of Immunome’s trial operations capabilities as well as leading various trial oversight activities and operational initiatives.   

Responsibilities

Monitoring Strategy & Trial Oversight  

• Own and evolve Immunome’s clinical monitoring strategy, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site, remote, and centralized), and standardize monitoring plans, KPIs, oversight activities, and dashboards across all trials and monitoring vendors in alignment with study risk profile, phase, and complexity, including review of protocols and study document for monitoring and trial operations feasibility.  
• Establish monitoring standards, templates, and best practices, including monitoring plan and report templates, and monitoring oversight programs.  
• Design and implement Immunome’s contract field monitoring team, including staffing model, sourcing, onboarding, and oversight framework.  
• Lead monitoring oversight across Immunome's clinical portfolio from site qualification through close-out, ensuring monitoring visits, source data verification, reporting and issue resolution meet timelines, quality standards, and regulatory expectations.  
• Identify and escalate site-level risks, protocol deviations, and data quality issues; drive rood cause analysis and corrective and preventative actions (CAPAs).  

Clinical Operations Leadership  

• Build, lead, and mentor high-performing teams.  
• Conduct or oversee monitoring training and oversight visits to ensure consistent monitor performance and data quality across studies.  
• Partner with Project Delivery, Clinical Site and Trial Operations, and Clinical Development Systems to support study and vendor oversight, ensure inspection readiness across trials through QC reviews, KPI monitoring, and ongoing issue identification, trend analysis, and resolution.  
• Support long-term resource planning and department growth.   
• Champion a culture of accountability, collaboration, and continuous improvement.   

Vendor and CRO Management  

• Lead selection, management and oversight of contract field monitoring staffing partners and vendors with delegated monitoring responsibilities, ensuring consistent quality, performance, and KPIs across all contract monitors and CRO-provided monitors.  
• Ensure vendor compliance with contractual obligations, timelines, monitoring quality standards, and performance metrics.  
• Contribute to governance, vendor oversight, and quality management and improvement processes for effective monitoring activities.  

Quality Assurance and Regulatory Compliance  

• Ensure monitoring and TMF activities adhere to ICH-GCP, FDA, EMA, and global regulatory requirements.  
• Partner with Quality Assurance on inspection readiness, audit response, and corrective actions related to m