Senior Manager, Local Study Operations

Amgen, Inc.; Stockholms kommun; On-site; SEK 900,000 - 1,400,000; Full time

Job summary

Amgen, Inc. in Sweden seeks a Local Study Operations Line Manager to drive end-to-end study portfolio delivery across the country. You will oversee LSOMs, mentor teams, and ensure high-quality trial execution in line with regulatory standards.

Key responsibilities include risk assessment, resource planning, and cross-functional collaboration with study strategy and country teams to optimize portfolio outcomes.

Qualifications

• Minimum of 2 years direct people management or leadership experience.
• Strong background in clinical execution within biopharma or CRO settings.

Responsibilities

• Ensure successful delivery of the study portfolio assigned to LSOMs across the country.
• Oversee LSOMs' fulfillment of responsibilities from feasibility to study close-out.
• Monitor portfolio progress, provide risk and quality oversight, and support issue escalation.

Skills

People Management

Clinical Trials

Portfolio Management

Regulatory Knowledge

Vendor Management

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

Career Category: Clinical Development

Job Description

Local Study Operations Line Manager

What you will do:

• 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.

What we expect of you

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

Salary Range

SEK - SEK

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

For union related matters, please contact: [e-mail]