Study Oversight Senior Manager

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Amgen is seeking a Study Oversight Senior Manager to coordinate and oversee global clinical trial activities, ensuring quality and compliance across FSP resources. The role emphasizes staff development, supplier oversight, and cross-functional collaboration across clinical operations.

The position requires strong leadership, risk management, and a proven track record in managing complex regulatory and trial delivery processes across regions, with on-site involvement as needed.

Qualifications

• Doctorate, Master's, Bachelor's, or equivalent with significant clinical leadership experience.
• Experience leading teams or programs and directing resource allocation.
• Experience overseeing clinical research suppliers (CROs, labs, imaging).

Responsibilities

• Manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance adherence.
• Serve as secondary contact for FSP supplier-related concerns within the country.
• Mentor, train, and support SOM Mgr. development.
• Oversee FSP supplier performance for study milestones and quality targets.
• Coordinate with LSOM leaders to maintain staff oversight and quality in Amgen trials.

Skills

People management

Cross-functional collaboration

Project management

Education

Doctorate + 2 years clinical execution OR Master's + 6 years OR Bachelor's + 8 years OR Associate's + 10 years OR High school/GED + 12 years

Job description

Study Oversight Sr Mgr

Responsibilities:

• Manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and compliance adherence.
• Serve as secondary contact and escalation point for FSP supplier-related concerns within the country.
• Mentor, train, and support professional development of SOM Mgr.
• Serve as point of contact for FSP supplier resource/capacity management, portfolio planning, and prioritization from study startup to close-out.
• Ensure oversight of supplier performance (tracking against metrics; assuring quality of work).
• Identify, escalation, and resolve quality and trial delivery issues.
• Collaborate with LSOM Senior Managers and/or LSOM AD to ensure appropriate staff oversight and maintain quality throughout Amgen clinical trials (including occasional on-site quality visits).
• Drive consistent communication between SOM Mgr, FSPs, and sites; ensure alignment with global strategies.
• Escalate issues to the County-Hub Head GSSO.
• Aggregate and communicate country-wide issues; provide country-aggregated view on FSP trends/challenges to senior management.
• Oversee FSP supplier performance for study milestone achievement and quality targets.
• Support inspection readiness; support local country site audits and regulatory inspections when applicable.
• Support maintenance of Amgen investigator site relationships in country.
• Participate in cross-functional task forces/process improvement groups.

Basic Qualifications:

• Doctorate + 2 years clinical execution OR Master's + 6 years OR Bachelor's + 8 years OR Associate's + 10 years OR High school/GED + 12 years.
• Plus minimum 2 years experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.

Preferred Qualifications:

• 7 years life sciences/medically related experience, including 4 years biopharmaceutical clinical research on clinical trials (biotech/pharma/CRO).
• Experience managing multiple teams/direct reports across clinical functions/trials.
• Experience overseeing clinical research suppliers (CROs, central labs, imaging, etc.).
• Experience managing clinical operations across region; strong understanding of local regulatory requirements for global clinical trials.

Benefits (Total Rewards highlights):

• Competitive health/welfare plans, retirement/savings plan, life/disability insurance, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans and company shutdowns; flexible work/remote arrangements where possible.