05 ago
|
Amgen Inc. (Ir)
|
España
05 ago
Amgen Inc. (Ir)
España
Local Study Operations Line Manager
Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease— we reach millions of patients each year.
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What you will do
- Lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies.
- Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM.
- Help foster, enhance, and sustain an optimal clinical research environment in partnership with the Country GSSO Head that supports global R&D; objectives.
- 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.
What we expect of youBasic Qualifications
- Doctorate degree & 2 years of clinical execution experience
- Master’s degree & 6 years of clinical execution experience
- Bachelor’s degree & 8 years of clinical execution experience
- Associate’s degree & 10 years of clinical execution experience
- 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.
Preferred Qualifications
- 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience.
- Experience managing multiple teams / direct reports across multiple clinical functions / trials.
- Experience at, or oversight of, clinical research vendors (CROs, 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 you can expect of us
- Competitive benefits package, including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus program.
- Stock‑based long‑term incentives.
- Time‑off plans and bi‑annual company‑wide shutdowns.
- Versátil work models, including remote work arrangements where possible.
- Career development opportunities.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. xqbhyrx Please contact us to request accommodation.
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📌 Sr Mgr Local Study Operations (España)
🏢 Amgen Inc. (Ir)
📍 España