出海雷达

高级经理 本地研究运营

Senior Manager Local Study Operations

职能支持限定地区(需当地身份)日间重叠约 2 小时,需偶尔早起或晚睡
公司Amgen
薪资未公开
工作地点Belgium
地域资格限定地区(需当地身份)
时区要求日间重叠约 2 小时,需偶尔早起或晚睡
用工类型Full Time
发布时间12 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 Belgium 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。
作息提示:日间重叠约 2 小时,需偶尔早起或晚睡。

职业类别
临床开发
职位描述
职位:本地研究运营主管经理

你将负责
让我们一起行动,改变世界。在此职位中,你将负责本地研究运营主管的技能发展,确保在该国有效实施试验,并与全球战略保持一致。你将通过本地研究运营主管(LSOM)的领导来监督该国研究组合的交付——管理范围、时间表和预算。与国家GSSO负责人紧密合作,你将帮助培育、提升和维持一个支持全球研发目标的临床研究环境。此外,你将通过整合最佳实践、推动数字化创新以及促进团队间的知识共享,推动LSOM执行的一致性和持续改进。

  • 确保分配给LSOM的研究组合成功交付。
  • 监督LSOM在所负责国家组合中的职责履行,从可行性研究到试验结束。
  • 监控组合进展,提供风险和质量监督,并为LSOM提供问题升级和解决支持。
  • 管理LSOM和LSOM供应商的绩效,以保证高质量的研究执行,作为本地研究挑战的主要升级点,推动解决方案,并确保国家内组合目标的达成。
  • 指导、培训和支持LSOM的职业发展,使他们能够管理复杂的试验。
  • 建立并维护一支高绩效团队。
  • 促进研究策略团队与本地研究团队之间的紧密合作,以有效管理所分配的组合。
  • 在国家团队之间促进跨职能协作,以确保国家组合的成功交付。
  • 支持基于国家能力和发展潜力的研究部署决策讨论。
  • 主动评估风险、质量趋势和资源需求;实施缓解策略,并推动国家运营的持续改进。
  • 领导提高运营效率的举措,并鼓励最佳实践的分享。
  • 管理LSOM之间的资源分配和工作量分发,包括FSP和FTE人员,以优化试验执行并符合全球优先事项。
  • 确保遵守适用的法规和质量标准。
  • 与国家负责人协作并提供支持
查看英文原文

Career Category
Clinical DevelopmentJob Description
Position: Local Study Operations Line Manager
What you will do
Let’s do this. Let’s change the world. In this role, you will lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies. You will oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM. Working in close partnership with the Country GSSO Head, you will help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives. Additionally, you will 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.

Basic Qualifications:

  • 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
  • In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

  • 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

.Salary Range
EUR - EUROriginally posted on Himalayas

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