EDC开发工程师（Medidata RAVE 和 Zelta v1.0）
EDC Developer (Medidata RAVE and Zelta v1.0)
医学在这里不断前进，你也将随之成长
临床试验、安全性研究和审计使安全且创新的以药物为中心的医疗成为可能。作为Ergomed集团的一部分，你帮助患者受益，让他们体验更多生命中的重要时刻。我们的客户是生物制药公司，患者是我们存在的意义。
Ergomed集团汇集了Ergomed CRO、PrimeVigilance、Prudentia和ADAMAS Consulting，帮助生物制药公司开发、交付并保障肿瘤学、罕见病及其他复杂医学领域的疗法。在集团内，我们的团队将临床试验、安全系统和质量数据所产生的信号转化为洞察力，帮助为全球患者带来更安全的治疗方案。
指导我们工作的科学与分析要求很高。而这就是我们擅长的地方。然而，真正定义我们的，是我们如何协作。跨越国家、文化和时区，我们以善意、好奇心和共同的目标感，投入到真正重要的工作中。这里欢迎各种想法，期待持续成长，每个人都有机会真正改变患者的生活。
无论你是职业生涯初期还是拥有数十年经验，我们都希望你因你的工作和你的身份而被重视。如果这正是你一直在寻找的环境，我们很期待收到你的来信。
该职位也可在我们任何欧洲地点工作
在ERGOMED数据管理（DM）部门的EDC开发者负责所有与复杂项目中EDC应用程序构建相关的任务。EDC开发者是在数据管理总监的指导下工作，并由项目数据经理在项目层面进行监督。
角色与职责
· 根据数据标准（CDASH）、研究方案和标准eCRF模板，构建EDC系统结构、工作流程、编辑检查及用户角色和权限；包括但不限于：
· 随机化
· ePRO（包括许可、验证和翻译）
· 试验药物管理
· 针对性SDV
· 其他附加（非核心）EDC功能
· 创建与EDC系统相关的所有研究级别文档，包括但不限于：
· 规格说明
· 测试计划
· 研究特定的培训材料
· 在变更控制流程下执行EDC系统的上线后更改及适用报告应用的更改
- 必须具备Medidata RAVE和Zelta v1.0经验
- 生命科学专业本科或研究生学历
查看英文原文
Medicine moves forward here. So will you.
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.
The position is also available in any of our European locations
The EDC Developer within the ERGOMED Data Management (DM) department is responsible for all tasks linked to the building of the EDC application for complex projects. The EDC Developer represents a position under direction of the Director of Data Management, with oversight by the Project Data Manager on a project level.
ROLE AND RESPONSIBILITIES
· Creates EDC system in terms of structure, workflow, edit checks and user roles & permissions; based on data standards (CDASH), study protocol and standard eCRF templates. Including, where applicable:
· Randomisation
· ePRO (including licensing, validation & translation)
· IMP Management
· Targeted SDV
· Any other additional (non-core) EDC functionality
Creates all study level documentation related to EDC System, including, but not limited to:
· Specifications
· Test Plans
· Study specific training materials
· Performs post-live changes to EDC system and applicable reporting applications under Change Control process
- Medidata RAVE and Zelta v1.0 experience is essential
- Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college
- Prior experience in EDC system creation and Edit Check programming is a must
- Effective communication skills
- Cooperative and team-oriented approach
- Self-motivation and ability to work independently
- Proficiency in data standards (CDASH & SDTM) and application to EDC system creation, CDASH Certification preferred
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
· Quality: we hold ourselves to the standard patients deserve.
· Integrity and trust: we do the right thing, especially when it is hard.
· Drive and passion: we care about the outcome, because someone is waiting on it.
· Agility and responsiveness: we move quickly, because patients cannot wait.
· Belonging: everyone is welcome, and every voice counts.
· Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.