临床研究构建师-菲律宾
Clinical Study Builder-Philippines
Description
Clinical Study Builder 将与数据管理和统计人员紧密合作，设计和开发电子病例报告表（eCRFs）、访视日程安排及相关的数据质量检查，用于医学研究项目。该职位需要在动态且协作的环境中工作。此外，解决方案的创建包括实施、测试和系统集成。Clinical Study Builder 主要负责 Rave CDMS，但也可能被要求使用其他 EDC 系统（如 Medrio 或 Veeva）构建 CRF。
此外，该职位需按照适用的监管要求、行业指南和 Indero 标准操作规程（SOP）开展所有活动，同时尊重 Indero 对客户要求和时间表的承诺。
具体而言，Clinical Study Builder 需要：
- 根据方案要求，开发 Rave、Veeva 和 Medrio CRF、文件夹、编辑检查、派生逻辑、集成、迁移和报告的编程/配置。
- 设置 Coder、本地实验室、定向 SDV 模块。
- 领导 eCRF 设计和评审会议。
- 提供用户支持和技术支持。
- 开展最终用户培训。
- 与首席数据经理协同工作。
- 与供应商合作伙伴有效配合进行测试和部署。
- 及时排查并解决技术问题。
- 参与 Rave CDMS SOP 的定义、编写和更新。
Requirements
Education
· 本科或硕士学历，相关专业；
Experience
· 至少 2-4 年 Rave CDMS 项目构建经验；
Knowledge and skills
· 持有 Rave 项目构建师认证者优先。
- 具有 Medidata Rave 构建经验者优先。
- 精通病例报告表设计、数据库编程。
- 能够同时领导多个项目构建或发布后的变更。
- 了解药物研发流程及适用法规，包括良好临床实践（GCP）、ICH 指南。
- 组织能力强，注重细节，具备有效的项目规划和时间管理能力。
- 英语口语和书面沟通能力强。
- 能在快节奏环境中工作，具备灵活应对和优先处理多项任务的能力。
Our company
The work environment
在 Indero，您将与才华横溢、积极进取的同事一起工作。我们的价值观是协作、创新和可靠性。
查看英文原文
Description
The Clinical Study Builder will work closely with data management and statistical staff to design and develop electronic case report forms (eCRFs), visit schedules and associated data quality checks for medical research studies. This position is required to work in a dynamic and collaborative environment. In addition, solution creation includes implementation , testing, and system integrations. The Clinical Study Builder will work principally on Rave CDMS, but might also be requested to build CRF using different EDC systems, like Medrio or Veeva.
In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines
More specifically, the Clinical Study Builder must:
- Develops programming/configuration of Rave, Veeva and Medrio CRFs, folders, edit checks, derivations, integrations, migrations, and reports, based on protocol requirements.
- Sets up Coder, Local Lab, Targeted SDV modules.
- Leads eCRF design and review meetings.
- Provides user support and technical support.
- Conducts end user training.
- Works collaboratively with Lead Data Managers.
- Works effectively with vendor partners in testing and deployment.
- Troubleshoots and resolves technical issues in a timely manner.
- Participates in the definition, writing and updating of Rave CDMS SOPs
Requirements
Education
·
B.Sc. or M.Sc, or in a related field of study;
Experience
· Minimum of 2-4 years of Rave CDMS study build experience;
Knowledge and skills
- Certified Rave Study Builders preferred.
- Medidata Rave build experience preferred.
- Detailed knowledge and experience in case report form design, programming databases;
- Must be able to lead multiple study builds or post-release changes at the same time;
- Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
- Highly organized and detail-oriented with effective project planning and time management skills.
- Strong verbal and written communication skills in English;
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
Work location
Note that this opening is for a home-based position in Philippines. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Philippines.
Originally posted on Himalayas