数据负责人（南非居家办公）
Data Team Lead (Home Based - South Africa)
你是否希望加入一家你的贡献真正重要的公司，并成为一支有支持力、创新的团队的一员？MMS 是一家获奖的、以数据为导向的临床研究组织（CRO）。我们自豪于是一家经过认证的优秀工作场所，因卓越的企业文化和行业领先的员工保留率而受到认可。我们通过经验证的科学方法，为制药、生物技术和医疗器械行业提供复杂试验数据和监管提交挑战的支持。MMS 在四大洲拥有全球业务，不仅保持了行业领先的客户满意度评级，还营造了一个协作且包容的工作环境，让员工能够茁壮成长。加入 MMS，成为塑造临床研究未来团队的一员。
了解更多关于我们令人兴奋的机会，以及为什么 MMS 是提升你职业生涯的理想之地。访问或关注 MMS 的 LinkedIn 页面。
数据团队负责人
职位职责
- 熟练使用 Microsoft Office 应用程序。
- 了解 ICH、21CRF 第 11 部分、ISO 9001 和 ISO 7001。
- 能够开发 eCRF、CRF 填写指南、编辑检查规范和 DMP。
- 创建用于研究团队使用的研究跟踪和指标报告。
- 监督 CRF 跟踪和数据录入，整合外部电子数据，数据验证和审查，查询处理与解决，不良事件和药物编码，SAE 核对，数据库锁定和数据库 QC 审计。
- 执行 EDC 和集成系统的用户验收测试（UAT），包括测试计划和脚本的开发。
- 协助准备培训站点/用户对 EDC 应用程序和 UAT 的培训。
- 具备研究实施活动的最终用户知识，包括查询管理、标准报告和在多个 EDC 系统中提取数据。
- 领导一个客户的单个项目或小型 DM 项目团队。
职位要求
- 科学、医学、临床学科或相关领域的大学毕业生，或具有相关经验。
- 需要至少 5 年的数据团队负责人或类似领域的工作经验。
- 精通科学原理和概念。
- 在该领域有杰出领导声誉，持续表现出色并取得成就。
- 熟练使用 Microsoft Office 应用程序。
- 具有临床试验和药品开发的实际经验者优先。
- 良好的沟通能力，愿意与他人合作，清晰理解需求并解决问题。
查看英文原文
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.
Data Team Lead
Roles and Responsibilities
- Proficient with MS Office applications.
- Understand ICH, 21CRF Part 11, ISO 9001 and ISO 7001.
- Ability to develop eCRFs, CRF Completion Guidelines, Edit check specs, and DMP.
- Create study tracking and metric reports for use by the study team.
- Oversight of CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.
- Perform user acceptance testing (UAT) of EDC and integrated systems including development of test plan and scripts.
- Assist with preparation for training sites/users training on EDC applications, and UAT.
- End user knowledge for study conduct activities including queries management, standard reporting and extracting data in multiple EDC systems.
- Lead studies or small DM project teams for one client.
Job Requirements
- College graduate in scientific, medical, clinical discipline or related field, or related experience.
- Minimum of 5 years’ experience as a Data Team Lead or similar field required.
- Expert knowledge of scientific principles and concepts.
- Reputation as emerging leader in field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.
Should you not receive a response on your application within 14 days, please consider your application unsuccessful.
Originally posted on Himalayas