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Sr Mgr Local Study Operations

AmgenAmgen·Biotechnology

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Posted

2 days

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About the role

Career Category

Clinical Development

Job Description

Accountabilities

  • Lead the skill development of Local Study Operations Senior Managers, ensuring the effective implementation of trials within the country and alignment with global strategies.
  • Oversee the delivery of the country’s study portfolio—including scope, timelines, and budgets—through the management of LSOM Senior Managers.
  • Collaborate with the Country GSSO Head to foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives.
  • Promote alignment and continuous improvement in LSOM execution by integrating best practices, digital innovations, and facilitating knowledge sharing among team members.

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.

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Aplyr's read

Amgen is a biotechnology leader focused on innovative therapeutics in oncology, cardiovascular, and inflammation, attracting professionals in science, engineering, and data analytics.

Synthesized from recent postings & public sources

What's promising

  • Strong focus on cutting-edge biotechnology and human therapeutics.
  • Diverse career opportunities in scientific, engineering, and data roles.
  • Commitment to addressing serious health conditions like cancer and cardiovascular disease.

What to watch

  • Highly competitive industry with constant innovation demands.
  • Regulatory challenges in developing and marketing new therapies.
  • Potential for high-pressure work environment due to ambitious goals.

Why Amgen

  • Pioneering in biologic therapies with a focus on serious diseases.
  • Robust pipeline of innovative drugs in various therapeutic areas.
  • Global presence with a strong emphasis on research and development.

Aplyr’s read is generated by AI from public sources. Was it useful?

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About Amgen

Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. The company focuses on areas such as oncology, cardiovascular disease, and inflammation.

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