Senior Manager, Local Study Operations

🕒 Agosto 20

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $151.988 - $205.630 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Lead the skill development of Local Study Operations Managers • Ensure effective trial implementation within the country and alignment with global strategies • Oversee delivery of the country’s study portfolio, including scope, timelines, and budgets • 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 • 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 • Lead operational efficiency and best-practice 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 and escalations

🎯 Requisitos

• 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 • 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 • Strong understanding of local regulatory requirements around global clinical trials

🏖️ Benefícios

• 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 • 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 • Financial plans with opportunities to save towards retirement or other goals • Work/life balance

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