研究启动经理
Study Start-up Manager
### **职业类别**
临床
### **职位描述**
职位描述
**加入安进为患者服务的使命**
在安进，如果你觉得自己是更大事业的一部分，那是因为你确实是。我们共同的使命——为患有严重疾病的患者服务——推动着我们所做的每一件事。
自1980年以来，我们在对抗世界上最难治愈的疾病方面，帮助开创了生物技术的世界。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年影响数百万患者。作为安进团队的一员，你将帮助对患者的生活产生持久的影响，我们研究、制造并提供创新药物，帮助人们活得更长、更充实、更快乐。
我们获奖的文化是协作、创新且以科学为基础的。如果你热衷于挑战以及其中的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生命，同时改变你的职业生涯。
**研究启动中心 – 研究启动经理**
**你将负责**
让我们一起行动，改变世界。在这个关键的职位中，你将推动临床研究启动活动的规划和执行，确保试验高效、合规，并达到最高质量标准。
- 从全球到本地，领导临床研究启动活动的规划和交付，确保时间表、质量、预算和监管合规性得到满足。
- 负责并管理研究启动计划和里程碑，保持对进度的监督，并解决相关问题以确保交付按计划进行。
- 作为跨职能启动团队的主要联系人，推动角色清晰度、责任归属和协作。
- 主动识别、评估和缓解风险，参与研究风险评估并确保研究及时启动。
- 与研究交付负责人、经理和当地团队紧密合作，提供明确的更新、解决方案和必要时的升级。
- 运用强大的运营和监管知识（例如ICH-GCP、提交和启动流程）以实现高质量的执行。
- 管理内部资源和外部供应商，以确保启动活动的高效和合规交付。
- 通过分享专业知识、指导同事和在SSU中心内开发最佳实践，为持续改进做出贡献。
**我们期待你做到**
我们每个人都不相同，但我们都利用自己独特的贡献
查看英文原文
### **Career Category**
Clinical
### **Job Description**
Job Description
**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. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Study Start Up Hub – Study Start-up Mgr**
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards.
- Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met.
- Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track.
- Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration.
- Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start.
- Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed.
- Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution.
- Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities.
- Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub.
**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.
**Basic Qualifications:**
- **Pharma Expertise:** Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required
- **Management Experience:** Requires experience leading and managing global teams and project management experience
- **Tech Skills:** No prior Veeva experience required
- Doctorate degree OR
- Master’s degree and 3 years of clinical execution experience OR
- Bachelor’s degree and 5 years of clinical execution experience OR
- Associate’s degree and 10 years of clinical execution experience OR
- High school diploma / GED and 12 years of clinical execution experience
- In addition to meeting at least one of the above requirements, you must have 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:**
- 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- Experience working in global clinical trial teams across multiple geographies
- Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
- PMP Certification
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
**The annual base salary range for this opportunity in the U.S. is [Talent Acquisition to input market pay range].**
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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. Please contact us to request accommodation.
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