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Amgen
Local Study Operations Manager TA Head
Career Insights for Clinical Research Manager
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What they do
A Clinical Research Manager is responsible for managing the day-to-day research operations of an organization undertaking clinical trials, usually pharmacological drug testing.
$153,723 / year median in the U.S.
Job Description
Job Details Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Local Study Operations Manager TA Head What you will do Lets do this. Lets change the world. In this role, you will lead and develop Local Study Operations Senior Managers, strengthening their leadership capabilities, functional expertise, and overall performance to ensure alignment with both global and country-level objectives. You will oversee the successful delivery of the countrys study portfoliomanaging scope, timelines, and budgetsthrough effective guidance and support of the LSOM Senior Manager team. Working closely with the Country GSSO Head, you will help cultivate a strong clinical research environment that supports global R D priorities. Additionally, you will drive strategic alignment and continuous improvement by standardizing processes across LSOM Senior Managers, promoting best practices, encouraging digital innovation, and facilitating the systematic sharing of knowledge and lessons learned across teams. Ensure the accountable delivery of the study portfolio assigned to LSOM Senior Managers. Oversee and guide the country study portfolio through effective leadership of LSOM Senior Managers, aligning execution with global strategies and local priorities. Provide strategic direction and support to LSOM Senior Managers in portfolio monitoring, driving local action plans, and resolving issues. Serve as the primary escalation point for complex or systemic local study challenges, facilitating resolution and ensuring portfolio targets are met with quality and efficiency. Lead the development and mentorship of LSOM Senior Managers to equip them for effective team leadership and operational excellence. Build and maintain a high-performing leadership team that promotes accountability, collaboration, and resilience across the LSOM organization. Facilitate close collaboration between global study strategy teams and local study teams to effectively manage the assigned portfolio. Oversee coordination among country functional teams to ensure successful delivery of the country portfolio. Support discussions on country study placements, considering country strengths and growth potential. Act as a key advisor for site selection, identifying priority sites and allocating resources accordingly. Support country-level risk assessments by proactively identifying and managing risks to delivery. Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards. Promote continuous operational improvements and encourage sharing of best practices. Manage resource allocation and workload distribution among LSOM Senior Managers and the broader LSOM team, including both FSP and FTE, to optimize trial execution and align with global priorities. Ensure compliance with relevant regulatory and quality standards. Collaborate with the country head to engage cross-functional stakeholders, align on trial deliverables, and manage escalations as needed. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.