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Local Study Operations Line Manager

Romania, Bucharest · Job Posted May 29, 2026
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Job Description

At Amgen, we are relentless in applying the highest ethical standards to our products, services and communications. Consistent with this, we expect all job applicants to act with honesty and integrity. Providing any false or misleading information, or omitting material information during the hiring process, may result in immediate disqualification from the hiring process or termination if already employed. We appreciate your cooperation in helping us uphold these standards.

Job Responsibility

  • 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

Nice to have

  • 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

What we offer

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
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