Study Oversight Manager

Responsibilities
• Act as the main liaison for FSP supplier(s) regarding resource and capacity management, portfolio planning, and prioritization throughout the study lifecycle from startup to close-out.
• Facilitate onboarding and training for FSP roles, including CRAs and CTAs.
• Monitor supplier performance by tracking metrics and ensuring the overall quality of work delivered by FSP staff.
• Identify, escalate, and resolve issues related to quality and delivery.
• Work closely with LSOMs to provide appropriate staff oversight and uphold quality standards across Amgen clinical trials, including occasional on-site quality visits.
• Promote effective collaboration between CRA and CTA roles and other country-specific positions to maintain consistent communication with sites and alignment with global strategies.
• Collect and communicate country-wide concerns by consolidating feedback from FSPs, offering senior management an aggregated view of FSP trends and challenges.
• Manage and oversee FSP supplier performance in relation to study milestones and quality objectives.
• Support inspection readiness, including local country and site-level audits, as well as regulatory inspections when necessary.
• Assist in maintaining relationships with Amgen investigators within the country.
• Participate in cross-functional task forces and process improvement initiatives.

Minimum Requirements
• Doctorate degree OR
• Master’s degree and 2 years of clinical execution experience OR
• Bachelor’s degree and 4 years of clinical execution experience
• Associate’s degree and 8 years of clinical execution experience OR 
• High school diploma / GED and 10 years of clinical execution experience
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting).
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• 5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
• Experience at, or oversight of, clinical research suppliers (CRO’s, central labs, imaging suppliers, etc.). Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry.
• Experience managing and supervising clinical trial staff across multiple studies.