Senior Manager, Local Study Operations

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $152k - $205.6k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Lead the skill development of Local Study Operations Managers and ensure effective trial implementation within the country aligned with global strategies • Oversee delivery of the country’s study portfolio, including scope, timelines, and budgets, through leadership of LSOMs • Foster and sustain an optimal clinical research environment supporting global R&D objectives • Ensure successful delivery of the study portfolio assigned to LSOMs • Oversee LSOM responsibilities from feasibility through study close-out • Monitor portfolio progress and provide risk and quality oversight • Support issue escalation and resolution • Manage LSOM and LSOM vendor performance and serve as the primary escalation point for local study challenges • Mentor, train, and support LSOM professional development • Build and maintain a high-performing team • Facilitate collaboration between study strategy and local study teams • Promote cross-functional collaboration among country teams • Support study placement decisions based on country capabilities and growth potential • Evaluate risks, quality trends, and resource requirements; implement mitigation strategies and continuous improvement • Lead operational efficiency and best-practice-sharing initiatives • Manage resource allocation and workload distribution across LSOMs, including FSP and FTE personnel • Ensure adherence to regulatory and quality standards • Collaborate with and support the country head on trial deliverables, stakeholder alignment, and escalations

🎯 Requirements

• Doctorate degree & 2 years of clinical execution experience OR Master’s degree & 6 years of clinical execution experience OR Bachelor’s degree & 8 years of clinical execution experience OR Associate’s degree & 10 years of clinical execution experience OR High school diploma / GED & 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, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company • Experience managing multiple teams / direct reports across multiple clinical functions / trials • Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.) • Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support