研究管理专员 II//临床试验管理专员 II
Associate, Study Management II//CTM II
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在多个关键治疗领域产生显著影响，包括免疫学、肿瘤学和神经科学——以及我们Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
• 负责按照质量标准（ICH/GCP、全球法规和艾伯维政策与程序）执行临床研究的一个或多个要素。
• 支持研究项目经理领导跨职能研究团队：
- 支持临床研究团队会议的准备（议程/纪要）
- 定期向跨职能团队和相关方更新研究进展；确保我们的CTMS系统保持最新
• 支持临床研究蓝图/方案及相关系统和文件（知情同意书、电子CRF、IRT、CSR）的开发。支持供应商选择、范围制定、管理和监督外部供应商，符合艾伯维的流程和程序以及适用法规。
• 负责为指定研究的研究团队、研究站点和供应商生成相关的培训内容。
• 主动识别并解决或上报研究相关的问题。
• 参与流程改进项目。
• 需要本科学位或同等学历，通常为护理或科学领域；持有护理副学士学位并具备相关经验的注册护士也接受。
• 建议拥有两年制药相关/临床研究相关经验或同等专业经验。
• 展现出分析和批判性思维能力。
• 具备良好的沟通能力。
艾伯维是一家平等机会雇主，致力于以诚信运营，推动创新，改变生活并服务社区。平等机会雇主/退伍军人/残疾人。
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
•Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
•Supports the Study Project Manager in leading the cross functional study team: o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
•Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR) Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
•Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
•Proactively identify and resolve and/or escalate study related issues
•Participates in process improvement initiatives
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•Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
•Two years of Pharma-related/clinical research related experience or professional equivalent desired.
•Demonstrates analytical and critical thinking skills.
•Possesses good communication skills.
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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html