Local Study Operations, Senior Manager

Amgen

11d

About The Position

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. 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 Operation Managers (LSOM's), 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 Global Study and Site Operations 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.

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
A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

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

Responsibilities

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, 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 requirements; 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.