Amgen
biotech
SrMgrLocalStudyOperations
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optimal for Senior candidates.
“Sr Mgr Local Study Operations at Amgen. Skills: process management, cross-functional coordination, vendor/stakeholder management, resource planning. Lead skill development of Local Study Operations Managers. Ensure effective trial implementation within the country”
What You'll Achieve.
Ensure effective trial implementation within the country; Ensure successful delivery of the study portfolio assigned to LSOMs; Ensure portfolio targets are met within the country; Optimize trial execution; Align with global priorities
Industry & Context.
Support issue escalation and resolution; Drive solutions; Proactively evaluate risks, quality trends; Implement mitigation strategies
What They're Looking For.
Must Have
Doctorate degree & 2 years of clinical execution experience, Master’s degree & 6 years of clinical execution experience, Bachelor’s degree & 8 years of clinical execution experience, Associate’s degree & 10 years of clinical execution experience, 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
Nice to Have
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, understanding of local regulatory requirements around global clinical trials
What You'll Do.
Lead skill development of Local Study Operations Managers
Ensure effective trial implementation within the country
Oversee delivery of country study portfolio
and sustain clinical research environment
Drive alignment and continuous improvement in LSOM execution
Integrate best practices
Promote digital innovation
Facilitate knowledge sharing across the team
Ensure successful delivery of study portfolio
Oversee LSOMs' fulfillment of responsibilities
Monitor portfolio progress
Provide risk and quality oversight
Support issue escalation and resolution
Manage LSOM and LSOM vendor performance
Serve as primary escalation point
Ensure portfolio targets are met
Build and maintain a high-performing team
Facilitate collaboration between study strategy team and local study teams
Promote cross-functional collaboration among country teams
Support discussions regarding study placement decisions
Proactively evaluate risks
Implement mitigation strategies
Drive continuous improvement in country operations
Lead initiatives to enhance operational efficiency
Encourage sharing of best practices
Manage resource allocation and workload distribution
Optimize trial execution
Align with global priorities
Ensure adherence to regulatory and quality standards
Collaborate with and support country head
Engage cross-functional stakeholders
Align on trial deliverables
How You'll Work.
Team & Collaboration
Work in close partnership with the Country GSSO Head; Facilitate close collaboration between the study strategy team and local study teams; Promote cross-functional collaboration among country teams; Collaborate with and support the country head in engaging cross-functional stakeholders
Process & Methodology
Manage scope, timelines, and budgets, Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out, Monitor portfolio progress, Provide risk and quality oversight, Support issue escalation and resolution for LSOMs, Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, Serve as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country, Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials, Build and maintain a high-performing team, Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio, Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio, Support discussions regarding study placement decisions based on country capabilities and growth potential, Proactively evaluate risks, quality trends, and resource implement mitigation strategies and drive continuous improvement in country operations, Lead initiatives to enhance operational efficiency and encourage sharing of best practices, Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, to optimize trial execution and align with global priorities, Ensure adherence to regulatory and quality standards where applicable, Collaborate with and support the country head in engaging cross-functional stakeholders, aligning on trial deliverables, and managing escalations
Full Job Description
## **Career Category** Research ## ## **Job Description** **Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Local Study Operations Line Manager** **What you will do** Let’s do this. Let’s change the world. In this role, you will lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies. You will oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM. Working in close partnership with the Country GSSO Head, you will help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives. Additionally, you will drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team. * Ensure the successful delivery of the study portfolio assigned to LSOMs. * Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to
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