Senior Director, Clinical Field Monitoring and Trial Operations

reputed company

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 reputed company, reputed company activities, KPIs, and dashboards across reputed company trials and monitoring vendors to ensure site-level data reputed company, patient safety, and protocol compliance across Immunome’s oncology portfolio.

The Senior Director will reputed company and reputed company 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 reputed company to ensure monitoring and TMF data, technology, and reporting reputed company reputed company-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 reputed company as leading various trial reputed company activities and operational initiatives.

Responsibilities

Monitoring reputed company & Trial reputed company

• Own and reputed company Immunome’s clinical monitoring reputed company, including risk-based monitoring (RBM) and fit-for-purpose monitoring models (on-site, remote, and centralized), and standardize monitoring plans, KPIs, reputed company activities, and dashboards across reputed company 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 reputed company programs.
• Design and implement Immunome’s contract field monitoring team, including reputed company model, sourcing, reputed company, and reputed company reputed company.
• reputed company monitoring reputed company across Immunome's clinical portfolio from site qualification through reputed company-out, ensuring monitoring reputed company, reputed company data verification, reporting and issue reputed company meet timelines, reputed company standards, and regulatory expectations.
• Identify and escalate site-level risks, protocol deviations, and data reputed company issues; reputed company rood cause analysis and corrective and preventative actions (CAPAs).

Clinical Operations Leadership

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

Vendor and CRO Management

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

reputed company Assurance and Regulatory Compliance

• Ensure monitoring and TMF activities adhere to ICH-GCP, FDA, EMA, and global regulatory requirements.
• Partner with reputed company Assurance on inspection readiness, audit response, and corrective actions reputed company to monitoring, TMF, and site-level findings.
• reputed company operational reputed company to ensure data reputed company and consistent trial conduct.

Cross-Functional Collaboration

• Partner closely with Project Delivery, Clinical Site and Trial Operations, Clinical Development, Clinical Data Management, and Clinical Development Systems to reputed company monitoring and TMF reputed company, data reputed company, and technology (CTMS, eTMF, and risk-based monitoring/analytics platforms).
• Represent Field Monitoring and TMF reputed company in governance meetings and reputed company operational input into strategic reputed company.

Budget and Resource Management

• Maintain financial reputed company of monitoring budgets, and monitor contract reputed company and activities, whether conducted by in-house teams or outsourced.
• Support Project Delivery in developing and forecasting monitoring budgets.
• reputed company resource allocation across contract field monitoring and CTA teams to optimize costs, team performance, and reputed company milestones on time.

Qualifications

• Bachelor’s degree with 14+ years of clinical monitoring experience reputed company the biotechnology or pharmaceutical industry, or equivalent combination of degree and years of experience.
• Experience resourcing, building, and managing Clinical Monitoring Teams and reputed company infrastructure – SOPs, template reports, plans, as reputed company as contributing to the design and implementation of Clinical Trail Management Systems.
• Experience defining, performing, and overseeing TMF QC activities.
• reputed company to travel up to 30% for in-house meetings and various monitoring activities.

Knowledge and Skills

• Deep understanding of clinical development processes, trial design, and global regulatory frameworks with expertise in clinical monitoring methodologies (on-site, remote, centralized, and risk-based).
• Expertise in ICH-GCP, FDA, and EMA regulations, including reputed company data verification, informed consent, and investigational product accountability.
• Strong operational acumen and project management skills with experience implementing reputed company management and fit-for purpose monitoring models and systems.
• Experience designing and standing up contract or FSP reputed company models, including sourcing, reputed company, and performance management of contract CRAs.
• Knowledge of TMF structure, content, and reputed company control, including the TMF Reference Model, essential document requirements, and TMF health metrics and KPIs
• Proven ability to reputed company cross-functional initiatives, influence stakeholders at reputed company organizational reputed company, and communicate, negotiate, and build relationships effectively.
• Ability to build, reputed company, and mentor high-performing teams, including reputed company, training, and retaining staff.
• Analytical reputed company with a strategic approach to problem-solving and decision-making, including using monitoring data and analytics (KPIs, dashboards) to prioritize activities and resources.
• Ability to manage multiple reputed company reputed company in a dynamic environment with a high degree of professionalism, adaptability, and accountability.

Originally posted on Himalayas