Senior Manager Local Study Operations

Career Category Clinical Development

Job Description
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 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.

Basic Qualifications

• 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
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• 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

Salary Range EUR
- EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen