Director of Clinical Site Monitoring and Oversight

Amgen

. Define and lead Amgen’s US clinical site monitoring strategy .

Posted 11/2/2026full-timeRemote • United StatesLead💰 $195,876 - $265,008 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in clinical research and monitoring strategy, with a strong focus on risk-based monitoring, regulatory compliance, and cross-functional leadership. Proven ability to develop and implement innovative monitoring methodologies and performance metrics across global clinical trials.

Highest-signal resume keywords

Clinical Research ExperienceRisk-Based Monitoring ExpertiseICH GCP KnowledgeLeadership in Clinical OperationsClinical Analytics Utilization

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Monitoring StrategyRisk-Based MonitoringCentralized MonitoringRemote MonitoringCRO OversightMonitoring TechnologiesData Visualization ToolsMonitoring Performance MetricsClinical Trial OversightRegulatory Compliance

Soft Skills

LeadershipChange ManagementRelationship ManagementOrganizational DevelopmentCommunication Skills

Tools & Technologies

RBQM PlatformsClinical Analytics ToolsMonitoring DashboardsPerformance Metrics Frameworks

Industry Keywords

ICH E6(R3)ICH E8(R1)Global Regulatory ExpectationsClinical OperationsClinical Quality

About the role

Key responsibilities & impact

Define and lead Amgen’s US clinical site monitoring strategy
Establish and maintain enterprise standards for on-site, remote, centralized, and risk-based monitoring activities
Ensure strategy and execution of field monitoring excellence while optimizing central monitoring
Drive evolution of monitoring methodologies through advanced analytics, automation, AI-enabled insights, and innovative oversight approaches
Serve as monitoring strategy business process owner and subject matter expert for senior leadership, governance committees, inspections, audits, and regulatory interactions
Collaborate with Clinical Operations leadership to integrate monitoring strategies into study planning, execution, and oversight models
Build and oversee a team of internal and FSP clinical research associates
Lead implementation and enhancement of risk-based monitoring approaches across the portfolio
Partner with Clinical Risk, Compliance, Systems, Data Management, Biostatistics, Medical, Quality, and FSP teams
Oversee monitoring plans, procedures, governance, and study-risk-based monitoring intensity
Establish monitoring oversight processes to identify, escalate, and mitigate quality, compliance, and operational risks
Provide strategic oversight of CRO monitoring performance
Establish monitoring performance metrics, dashboards, and governance frameworks
Lead escalation and resolution of systemic monitoring issues and compliance concerns
Lead, coach, and develop CRA leaders, including performance management and succession planning
Build organizational capabilities, resourcing, and operating models for regional portfolio requirements
Foster a high-performing, inclusive, accountable, and patient-focused culture across distributed teams
Lead organizational changes and adoption of new operating models, technologies, and monitoring approaches
Set regional delivery goals, operating expectations, and performance standards across clinical trial operations
Establish frameworks for monitoring performance metrics and best practices across hubs and countries
Advance centralized and analytical monitoring capabilities as part of the monitoring and RBQM strategy

Requirements

What you’ll need

Doctorate degree and 4 years of clinical research experience OR Master’s degree and 7 years of clinical research experience OR Bachelor’s degree and 9 years of clinical research experience
Minimum of 12 years of experience in clinical research, clinical operations, clinical quality, or related functions, including significant experience leading clinical monitoring strategy and oversight in global clinical trials
Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight
Demonstrated success developing and implementing monitoring strategies across multiple therapeutic areas and phases of development
Strong expertise in risk-based monitoring, centralized monitoring, remote monitoring, and CRO oversight models
Experience utilizing clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools
Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization
Strong leadership, change management, relationship management, and organizational development capabilities
Excellent communication, presentation, and stakeholder management skills
Ability to travel up to 25%

Benefits

Comp & perks

Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Work/life balance support