出海雷达

数据经理(编程及开发EDC系统专家)

Data Manager (Expert in Programming & developing EDC systems)

其他未标注地域
公司Ergomed
薪资未公开
工作地点Pune, MH, India
地域资格未标注地域
时区要求无特别要求
用工类型Full-time
发布时间23 天前
数据来源SmartRecruiters
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医学在这里不断前进,你也将随之进步。
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。在集团内部,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和分析工作要求很高。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真正重要的工作中。这里欢迎各种想法。我们期待成长。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。如果这听起来就是你一直在寻找的地方,我们很期待收到你的来信。

ERGOMED数据管理(DM)部门的数据经理负责数据库测试、查询管理、实验室参考范围管理、严重不良事件核对、供应商数据核对以及其他与数据管理相关的任务。数据经理是在数据管理经理指导下工作,并由项目数据经理在项目层面进行监督。
数据经理负责从方案启动到数据库锁定数据清理活动,支持各种数据管理和EDC相关工作,包括:
研究启动
· 验证EDC系统及相关的DM报告或列表
· 验证EDC和SAS编辑检查
· 管理和创建EDC用户账户
· 按照首席数据经理(LDM)或项目的要求更新和维护DM文档
· 执行特定活动,以协助在数据库和编辑检查开发期间创建数据库规范、数据库构建和用户验收测试
研究实施(支持多个中等复杂度/复杂试验,接受最少监督)
· 可能输入数据

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 Data Manager within the ERGOMED Data Management (DM) is responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager, Data Management and is supervised by the Project Data Manager on a project level.
The Data Manager is responsible for supporting various data management and EDC activities from initiation of protocol through database lock data cleaning activities including:
Study start-up
· Perform validation of EDC Systems and associated DM reports or listings
· Perform validation of EDC and SAS edit checks
· Manage and Create EDC user accounts
· Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
· Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)
· May enter Data from trial documents into data entry system
· May perform Medical Coding
· Manage the entry, review, and tracking of Local/Central Lab reference ranges
· Attend internal/external teleconferences as needed
· May create and review study metric reports for internal/external project teams
· Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
· Provide the PDM with status updates on tasks that are assigned
· Escalates significant issues promptly to the study team
Study Closure
· Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)

Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline
· 4-8 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment

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.

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