Senior Study Oversight Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $167.2k - $226.2k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Manage all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and adherence to compliance standards • Serve as the secondary contact and escalation point for FSP supplier-related concerns within the country • Mentor, train, and support the professional development of SOM Managers • Manage FSP supplier resources and capacity, including portfolio planning and prioritization from study startup to close-out at country level • Oversee supplier performance, including metrics tracking and quality assurance of FSP staff work • Identify, escalate, and resolve quality and trial delivery issues • Collaborate with LSOMs Senior Managers and/or LSOM Associate Director to maintain quality throughout Amgen clinical trials, including occasional on-site quality visits • Ensure effective collaboration between SOM Managers and consistent communication with FSPs and sites • Escalate issues to the Country-Hub Head GSSO • Aggregate and communicate country-wide FSP trends and challenges to senior management • Oversee FSP supplier performance against study milestones and quality targets • Support inspection readiness, local country site-level audits, and regulatory inspections • Support maintenance of Amgen investigator site relationships in-country • Participate in cross-functional task forces and process improvement groups

🎯 Requirements

• Doctorate degree and 2 years of clinical execution experience OR Master’s degree and 6 years of clinical execution experience OR Bachelor’s degree and 8 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • 7 years work experience in life sciences or medically related field (preferred) • 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company (preferred) • Experience managing multiple teams/direct reports across multiple clinical functions/trials (preferred) • Experience at, or oversight of, clinical research suppliers such as CROs, central labs, and imaging suppliers (preferred) • Experience managing clinical operations across relevant geography/region, including strong understanding of local regulatory requirements around global clinical trials (preferred)

🏖️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible • Career development opportunities • Work/life balance • Financial plans with opportunities to save towards retirement or other goals