Senior Manager, Study Oversight & FSP Partnerships

BioSpace; Washington (District of Columbia); Hybrid; USD 167,000 - 226,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Stock-based incentives

Flexible work arrangements

Paid time off

Job summary

Amgen seeks a Study Oversight Senior Manager to lead all country-level FSP resources (CRA, CTA, LSOM) ensuring quality, efficiency, and compliance. You will serve as the secondary contact for country-level FSP supplier concerns and drive strategic staff oversight across trials.

The role requires strong leadership in clinical execution with 2+ years of direct people management, and a track record in coordinating cross-functional teams, supplier performance, and regulatory readiness.

Qualifications

• Doctorate/Masters/Bachelors/Associates/High school diploma with substantial clinical execution experience.
• Minimum of 2 years of direct people management or leadership experience.

Responsibilities

• Mentor, train, and develop SOM Mgrs and staff.
• Oversee FSP supplier resource/capacity management and portfolio planning.
• Monitor supplier performance and quality against metrics.
• Identify and resolve quality and trial-delivery issues.
• Collaborate with LSOMs Sn Mgs and LSOM AD for staff oversight.
• Ensure cross-functional communication with FSPs, sites, and global strategies.
• Escalate issues to County-Hub Head GSSO.
• Summarize country-wide FSP trends for senior management.
• Oversee milestone delivery and quality targets for FSPs.
• Support inspection readiness and regulatory site audits when applicable.
• Maintain investigator site relationships in country.

Skills

Leadership experience

People management

Clinical research coordination

Regulatory knowledge

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Job description

Amgen seeks a Study Oversight Senior Manager to lead all country-level FSP resources (CRA, CTA, LSOM) ensuring quality, efficiency, and compliance. You will serve as the secondary contact for country-level FSP supplier concerns and drive strategic staff oversight across trials.

The role requires strong leadership in clinical execution with 2+ years of direct people management, and a track record in coordinating cross-functional teams, supplier performance, and regulatory readiness.