Director of Clinical Site Monitoring and Oversight

This is a fully remote position, open to applicants in United States.

📋 Description

• Define and spearhead Amgen’s clinical site monitoring strategy in the US.

• Develop and uphold enterprise standards for on-site, remote, centralized, and risk-based monitoring activities.

• Ensure excellence in field monitoring strategy and execution while enhancing central monitoring.

• Propel the advancement of monitoring methodologies using advanced analytics, automation, AI-enabled insights, and innovative oversight techniques.

• Act as the business process owner for monitoring strategy and serve as a subject matter expert for senior leadership, governance committees, inspections, audits, and regulatory interactions.

• Collaborate with Clinical Operations leadership to seamlessly integrate monitoring strategies into study planning, execution, and oversight models.

• Build and manage a team of internal and FSP clinical research associates.

• Lead the implementation and improvement of risk-based monitoring approaches throughout the portfolio.

• Partner with Clinical Risk, Compliance, Systems, Data Management, Biostatistics, Medical, Quality, and FSP teams.

• Oversee monitoring plans, procedures, governance, and intensity of study-risk-based monitoring.

• Establish oversight processes for monitoring to identify, escalate, and mitigate quality, compliance, and operational risks.

• Provide strategic oversight of CRO monitoring performance.

• Create metrics, dashboards, and governance frameworks for monitoring performance.

• Lead the escalation and resolution of systemic monitoring issues and compliance challenges.

• Mentor, coach, and develop CRA leaders, including performance management and succession planning.

• Build organizational capabilities, resources, and operational models tailored to regional portfolio requirements.

• Cultivate a high-performing, inclusive, accountable, and patient-focused culture across distributed teams.

• Drive organizational changes and the adoption of new operating models, technologies, and monitoring strategies.

• Set regional delivery objectives, operational expectations, and performance standards across clinical trial operations.

• Develop frameworks for monitoring performance metrics and best practices across hubs and countries.

• Enhance centralized and analytical monitoring capabilities as part of the monitoring and RBQM strategy.

⛳️ Requirements

• 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.

• A minimum of 12 years of experience in clinical research, clinical operations, clinical quality, or related fields, with substantial experience in leading clinical monitoring strategy and oversight in global clinical trials.

• Extensive knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations related to risk-based monitoring and clinical trial oversight.

• Proven success in developing and executing monitoring strategies across various therapeutic areas and phases of development.

• Strong expertise in risk-based monitoring, centralized monitoring, remote monitoring, and CRO oversight models.

• Experience in utilizing clinical analytics, RBQM platforms, monitoring technologies, and data visualization tools.

• Demonstrated ability to influence senior stakeholders and manage complex cross-functional initiatives within a global matrix organization.

• Exceptional leadership, change management, relationship management, and organizational development skills.

• Excellent communication, presentation, and stakeholder management abilities.

• Willingness to travel up to 25%.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan featuring 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 feasible.

• Career development opportunities.

• Support for work/life balance.