出海雷达

高级专员,站点合同 - 德国 - 远程

Principal Specialist, Site Contracts - Germany - Remote

职能支持限定地区(需当地身份)
公司Lifelancer
薪资未公开
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
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 United States 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。

职位名称:高级专家,站点合同 - 德国 - 远程
工作地点:德国柏林
工作地点类型:远程
工作合同类型:全职
职位级别:
关于我们
我们是一家全球性的中型CRO,不断突破界限,创新和发明,因为治愈世界上最顽固疾病的道路不是由那些谨慎行事的人铺就的。而是由那些采取开创性、创造性方法并以质量和卓越实施它们的人所构建的。
我们是Worldwide Clinical Trials,我们是一支由3500多名专家、聪明的思考者、梦想家和实干家组成的全球团队,我们一起正在以最好的方式改变世界对CRO的体验。
我们的使命是每天带着激情和目标工作,改善生活,我们正在寻找同样重视这一追求的人。
为什么选择Worldwide
我们认为每个人都在为患者及其护理者带来巨大影响方面发挥着重要作用。从我们亲力亲为、易于接触的领导,到我们紧密协作和支持的团队,我们致力于让来自各种背景和经验的专业人士取得成功。我们优先培养一个多元和包容的环境,持续促进合作与创造力。我们自豪地成为一个人人都能做自己并每天被激励做出最佳工作的场所。加入我们!
Worldwide站点合同部门的工作内容

站点合同是任何CRO的重要职能,我们经验丰富的团队在行业内拥有数十年的经验,并具备扎实的法律经验。该部门负责审查、分析和起草临床研究站点合同、研究者合同和其他项目相关合同。我们的全球团队熟悉我们所处国家和站点的具体法律。我们与Worldwide法务部、研究团队、赞助商、研究者和/或临床站点协商并最终确定临床试验合同和服务合同。

你将负责
· 在国家和站点层面担任临床试验协议流程的领域专家(SME)
· 准备、协商和最终确定站点合同和预算
· 管理研究者预算,并作为合同相关沟通的关键联络人
· 解决协商问题和升级风险,推动流程改进,参与SOP开发并保持模板更新
· 与Worldwide团队进行联络和协作

查看英文原文

Job Title: Principal Specialist, Site Contracts - Germany - Remote
Job Location: Berlin, Germany
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Site Contract department does at Worldwide

Site Contracting is an essential function within any CRO, and our seasoned team spans decades of experience within the industry and possesses robust legal experience as well. The department is responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts and other project-related contracts. Our global team is familiar with the specific laws for the countries and sites we occupy. We negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, Sponsors, investigators, and/or clinical sites.

What you will do
· Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level
· Preparation, negotiation and finalization of site contracts and budgets
· Manage the Investigator Budget and act as a key liason for contract related communications
· Resolve negotiation issues and escalating risks, drive process for improvements, contribute to SOP develoment and keep templates updated
· Liaising and collaborating with Worldwide stakeholders as well as external stakeholders (such as sites, investigators etc.)
· Review and finalize Clinical Trial Agreements and/or any document associated including site budget, for completeness and accuracy
What you will bring to the role
· Mastery in negotiating complex contract terms with clinical sites and vendors
· In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
· Ability to explain complex contract terms clearly and concisely
· Leadership skills to guide and support junior contract specialists
· Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.
Your experience
· 3- 4 years of experience as a Senior Site Contracts Specialist or minimum 5 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry
· Bachelor's Degree or equivalent in business administration, finance, law, science or related field
· Proficiency with MS Word, Excel and Outlook
· Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas

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