数据监测分析师 - 基于选定的EMEA地区
Data Surveillance Analyst - based in selected EMEA locations
当我们的价值观一致时，我们能实现的没有极限。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都基于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，每个人都在为最终能帮助患者的疗法开发做出贡献。我们认真对待工作，带着同理心去做，并致力于带来改变。
这个居家办公职位面向选定的EMEA地区候选人开放。申请者必须位于指定的合格地点之一。
想象一下你在Parexel：
数据监测分析师（DSA）负责分析科学和操作数据，以支持数据监测流程并审查项目特定的质量容限。他们协助制定数据监测计划（DSP），并进行定义的项目审查。DSA还会参加内部和外部的数据监测会议，并向项目团队汇报相关发现。
你在Parexel的工作内容：
数据监测计划开发与技术配置：
- 支持制定稳健的数据监测计划，包括关键风险指标、质量容限和中心统计分析。
- 配置和维护数据监测技术（例如：CluePoints中央监查平台）：
- 为所有数据源创建数据导入映射
- 创建并设置标准和定制的KRIs
- 创建并设置统计分析参数
数据监测审查：
- 通过指定的技术和其他必要来源审查相关数据，以支持根据项目特定数据监测计划指定的DS分析师的审查，包括项目特定的质量容限。
- 在DS发现表、问题跟踪系统和其他适当的地方记录数据监测活动的发现。
- 提供反馈并与技术团队合作，识别符合业务和技术战略的潜在解决方案。
- 运用专业知识和判断力，识别和评估潜在的数据质量趋势、异常值和新出现的问题。在其他/相关方的输入和/或提供的指导（如适用）下，确定并实施适当的后续行动。
- 积极参与研究者及其他内外部会议
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
This home-based position is available to candidates in selected EMEA locations. Applicants must be based in one of the eligible locations.
Picture Yourself At Parexel:
The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. The DSA also attends internal and external Data Surveillance meetings, where they present relevant findings to the project team.
What You'll Do At Parexel:
Data Surveillance Plan Development and Technology Configuration:
- Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis.
- Configure and Maintain Data Surveillance technologies (e.g., CluePoints Central Monitoring Platform):
- Create data import mapping for all data sources
- Create and set-up standard and bespoke KRIs.
- Create and set-up statistical analysis parameters.
Data Surveillance Review:
- Review relevant data via the scoped technologies and additional sources as required to support reviews designated for the DS Analyst per the project specific Data Surveillance Plan, including project specific Quality Tolerance Limits.
- Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking system(s) and other as appropriate.
- Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy.
- Apply working knowledge and judgment to identify and evaluate potential data quality trend, outliers and emergent issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Recognize impact of study non-compliance/issues/delays/data quality signals and communicate/ promptly escalate to FL any site and/or study issues that require immediate action.
- Perform core reviews per DS Plan.
- Document instances of atypical data per DS Plan.
- Collaborate with DS Team Members to correlate findings from various sources.
- Support Project Leads with DS Review meeting, driving reviews and decisions as needed and agreeing on actions.
- Engage DS Team to compile signals/actions into client ready list.
- Support documentation of actions in CluePoints Issue Management system (links to IH for any on-site interventions required).
- Complete, share, and file Central Monitoring Report.
Here are a few requirements specific to this advertised role:
- University degree (medical, biological science, pharmacy, and/or data analytics).
- Fluent English.
- Hands-on programming experience in SAS, R, and/or SQL is a must-have.
- Experience with Risk-Based Quality Management (RBQM) processes and data surveillance methods.
- Familiarity with centralized monitoring and Data Driven Monitoring practices.
- Proficient in data analysis, trend identification, and issue triage.
- Proficient in relevant software: CTMS, EDMS, MS Office.
- Basic understanding of SDTM domains and data operations concepts.
- Experience with CluePoints would be a strong asset.
- Client-focused with strong quality orientation.
- Effective in matrix and global virtual team environments.
- Excellent interpersonal and communication skills, including presentation abilities.
- Strong time management and multitasking capabilities.
- Ability to work independently with minimal supervision.
Why join us:
Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours!
If this job does not sound like the next step in your career, but you know of someone who would be a perfect fit, send them the link to apply!
Originally posted on Himalayas