Senior Study Oversight Leader - Remote & Impactful

Amgen SA; Northern (KY); Hybrid; USD 167,000 - 226,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Bonus program

Stock incentives

Flexible remote work

Job summary

Amgen is seeking a Study Oversight Sr Mgr to manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance. You will serve as secondary contact for FSP supplier concerns within the country.

This role includes mentoring SOM Managers, coordinating supplier capacity and portfolio planning from study startup to close-out, overseeing performance against metrics, and supporting inspection readiness and regulatory inspections where applicable.

Qualifications

• Doctorate or equivalent with clinical execution experience
• Advanced degree with leadership/management experience in clinical operations
• Experience supervising teams and resource allocation
• Knowledge of regulatory requirements for global clinical trials

Responsibilities

• Mentor, train, and support SOM Mgr development and leadership
• Serve as the country point of contact for FSP supplier resource and capacity management
• Oversee supplier performance and quality across study milestones
• Ensure readiness for inspections and regulatory audits when applicable
• Collaborate with global and local teams to maintain quality and alignment

Skills

People management

Leadership

Cross-functional collaboration

Project management

Quality assurance

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a Study Oversight Sr Mgr to manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance. You will serve as secondary contact for FSP supplier concerns within the country.

This role includes mentoring SOM Managers, coordinating supplier capacity and portfolio planning from study startup to close-out, overseeing performance against metrics, and supporting inspection readiness and regulatory inspections where applicable.