Senior Manager Local Study Operations

Amgen; Belgique; Sur place; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Amgen Belgium is seeking a Local Study Operations Line Manager to lead LSOMs, overseeing the country trial portfolio and aligning with global R&D strategies. You will mentor LSOMs, manage budgets and timelines, and foster strong collaboration with country teams and study strategy to ensure high-quality trial execution.

This role emphasizes operational excellence, risk and quality oversight, and ongoing process improvements to support global clinical development objectives.

Qualifications

• Minimum 2 years direct people leadership or management experience.
• Experience leading study operations in clinical development.
• Strong knowledge of local regulatory requirements for global trials.

Responsabilités

• Lead LSOMs to deliver study portfolios within country scope, timelines, and budgets.
• Mentor LSOMs and build a high-performing team across the country.
• Collaborate with study strategy and local teams for successful trial delivery.
• Oversee vendor performance and escalation, ensuring quality and compliance.
• Drive continuous improvement and knowledge sharing across the team.

Connaissances

People management

Leadership

Portfolio management

Budget oversight

Risk & quality oversight

Cross-functional collaboration

Vendor management

Mentoring & development

Resource allocation

Process improvement

Formation

Doctorate + 2 yrs clinical execution

Master's + 6 yrs clinical execution

Bachelor's + 8 yrs clinical execution

Associate's + 10 yrs clinical execution

HS diploma + 12 yrs clinical execution

Description du poste

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

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Salary Range

EUR-EUR