Study Oversight Manager

Career Category Clinical Development Job Description Accountabilities • The Study Oversight Manager (SOM) is responsible for leading and managing the resourcing, collaboration, and performance of FSP suppliers at the country level. • Acts as the main contact and escalation point for FSP suppliers, working cross-functionally to support clinical study execution and ensure efficient, high-quality clinical trial results. • Works together with LSOMs to oversee key country-level suppliers involved in study delivery. 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.

Describe the knowledge and skills necessary to perform the duties of this role. Include a  combination of education, experience, knowledge, or the equivalent 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  Preferred Requirements (based off CTOM) • 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" Competencies • Demonstrates expertise in identifying site-level challenges, applying data-driven strategies,  and implementing corrective actions to optimize trial performance • Experience supporting change management initiatives, including updating of documentation  and processes • Skilled in planning and implementation of country level operational plan, enhancing  compliance, and