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Clinical Trial Risk Based Monitoring Jobs (NOW HIRING)

Jj

Specialist Oncology Risk Management

Raritan, NJ · On-site

Clinical Quality Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United ... Throughout the duration of the trial, theSpecialist executes data-driven, risk-based trial ...

Aerogen Ltd

Clinical Trial Manager

Morrisville, NC · On-site

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to ... This includes vendor management, monitoring subject safety and data collection, and ensuring ...

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Clinical Trial Risk Based Monitoring information

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How much do clinical trial risk based monitoring jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for clinical trial risk based monitoring in the United States is $39.99, according to ZipRecruiter salary data. Most workers in this role earn between $32.21 and $43.99 per hour, depending on experience, location, and employer.

How does a clinical trial risk based monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

How to become a clinical trial risk based monitoring?

To become a clinical trial risk-based monitor, candidates typically need a bachelor's degree in life sciences, healthcare, or related fields, along with experience in clinical research or monitoring. Certification such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) can enhance job prospects. Strong knowledge of Good Clinical Practice (GCP) guidelines and proficiency with electronic data capture (EDC) systems are also important.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What is clinical trial risk based monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

What are the key skills and qualifications needed to thrive in clinical trial risk based monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.
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Clinical Trial Risk Based Monitoring jobs near you
Infographic showing various Clinical Trial Risk Based Monitoring job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $83,169 per year, or $40 per hour.

Senior Director, Clinical Field Monitoring and Trial Operations

Immunome, Inc.

Remote

Full-time

Posted 5 days ago

Job description

Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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 monitoring, TMF, and site-level findings.
  • Drive operational excellence to ensure data integrity 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 align monitoring and TMF strategy, data flow, and technology (CTMS, eTMF, and risk-based monitoring/analytics platforms).
  • Represent Field Monitoring and TMF Oversight in governance meetings and provide operational input into strategic decisions.

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

Qualifications
  • Bachelor's degree with 14+ years of clinical monitoring experience within the biotechnology or pharmaceutical industry, or equivalent combination of degree and years of experience.
  • Experience resourcing, building, and managing Clinical Monitoring Teams and related infrastructure - SOPs, template reports, plans, as well as contributing to the design and implementation of Clinical Trail Management Systems.
  • Experience defining, performing, and overseeing TMF QC activities.
  • Able 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 source data verification, informed consent, and investigational product accountability.
  • Strong operational acumen and project management skills with experience implementing quality management and fit-for purpose monitoring models and systems.
  • Experience designing and standing up contract or FSP staffing models, including sourcing, onboarding, and performance management of contract CRAs.
  • Knowledge of TMF structure, content, and quality control, including the TMF Reference Model, essential document requirements, and TMF health metrics and KPIs
  • Proven ability to lead cross-functional initiatives, influence stakeholders at all organizational levels, and communicate, negotiate, and build relationships effectively.
  • Ability to build, lead, and mentor high-performing teams, including recruiting, training, and retaining staff.
  • Analytical mindset 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 complex projects in a dynamic environment with a high degree of professionalism, adaptability, and accountability.

Washington State Pay Range
$260,965-$309,341 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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