Amgen
SrMgrLocalStudyOperations
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“Sr Mgr Local Study Operations at Amgen. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. lead the skill development of Local Study Operations Managers. ensuring effective trial implementation within the country and alignment with global strategies”
What You'll Achieve.
Ensure the successful delivery of the study portfolio assigned to LSOMs; ensure portfolio targets are met within the country; optimize trial execution and align with global priorities
Industry & Context.
support issue escalation and resolution; driving solutions; implement mitigation strategies
Opportunity to work from abroad for a defined period during the year
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, 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 understanding of local regulatory requirements around global clinical trials
What You'll Do.
lead the skill development of Local Study Operations Managers
ensuring effective trial implementation within the country and alignment with global strategies
oversee the delivery of the country’s study portfolio—managing scope
and budgets—through the leadership of LSOM
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 study close-out
Monitor portfolio progress
provide risk and quality oversight
and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution
serving as the primary escalation point for local study challenges
and ensuring portfolio targets are met within the country
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
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
How You'll Work.
Team & Collaboration
Working 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
managing scope, managing timelines, managing budgets, portfolio management
Full Job Description
## **Career Category** Clinical ## ## **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. # **Position: 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
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