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About the Role

Join Amgen's mission to serve patients by leading the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and alignment with global strategies. Oversee the delivery of the country’s study portfolio, managing scope, timelines, and budgets through LSOM leadership. Foster an optimal clinical research environment and drive continuous improvement by integrating best practices and promoting digital innovation.

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.

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
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.

Skills

Clinical execution
People management
Team leadership
Project management
Program management
Resource allocation
Biopharmaceutical clinical research
Clinical trial management
Vendor management
Regulatory requirements
Digital innovation

Experience Level

2 years of clinical execution experience (with Doctorate)
6 years of clinical execution experience (with Master's)
8 years of clinical execution experience (with Bachelor's)
10 years of clinical execution experience (with Associate's)
12 years of clinical execution experience (with High School Diploma/GED)
2 years of people management or leadership experience
7 years work experience in life sciences or medically related field (preferred)
4 years biopharmaceutical clinical research experience (preferred)
Experience managing multiple teams / direct reports (preferred)
Experience at, or oversight of, clinical research vendors (preferred)
Experience managing clinical operations across relevant geography / region (preferred)

Education Level

Doctorate degree
Master’s degree
Bachelor’s degree
Associate’s degree
High school diploma / GED

Benefits

Competitive benefits

About the Company

Amgen's mission is to serve patients living with serious illnesses.
Pioneered the world of biotech in our fight against the world’s toughest diseases.
Focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease.
Reach millions of patients each year.
Research, manufacture, and deliver innovative medicines.
Award-winning culture is collaborative, innovative, and science based.