Senior Manager Local Study Operations

Amgen; Diegem; Sur place; EUR 110 000 - 170 000; Plein temps

Résumé du poste

Amgen in Belgium is seeking a Local Study Operations Line Manager to lead LSOM development and ensure effective trial implementation within the country, aligning with global strategies. You will oversee the delivery of the country study portfolio, managing scope, timelines and budgets through LSOM leadership.

You will mentor LSOMs, drive collaboration across local teams and vendors, and promote continuous improvement and best practices in study execution within the Belgian landscape.

Qualifications

• Minimum leadership experience directing teams, projects, or resource allocation.
• Experience in clinical research operations or life sciences preferred.
• Knowledge of regulatory requirements for global clinical trials.

Responsabilités

• Lead LSOMs to ensure delivery of the country portfolio from feasibility to study close-out.
• Oversee LSOM performance, risk, quality oversight, and issue escalation.
• Mentor and develop LSOMs for complex trials and promotions of best practices.
• Build a high-performing team and foster cross-functional country collaboration.
• Coordinate with the study strategy team and local study teams to achieve portfolio goals.
• Manage resources including FSP and FTE personnel to align with global priorities.

Connaissances

Leadership

People management

Cross-functional collaboration

Vendor management

Program/project management

Mentoring

Budget and timelines

Regulatory quality oversight

Digital innovation

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Description du poste

Position: Local Study Operations Line Manager

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