数据监控分析师
Data Surveillance Analyst
当我们的价值观一致时，我们能够实现无限可能。
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——对我们所做工作的深刻信念。
无论我们在Parexel做什么，都在为最终惠及患者的疗法开发做出贡献。我们把工作当作自己的事来做，带着同理心，致力于带来改变。
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标准。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。
关键职责：
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、质量容限标准和中心统计分析
- 配置和维护数据监测技术（例如Clue Points中心监控平台）
- 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关键风险指标
- 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所需来源审查相关数据，以支持根据项目特定数据监测计划指定给DS分析师的审查，包括项目特定的质量容限标准
- 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，找到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、审计和监管检查
- 识别研究不合规/问题/延迟/数据质量信号的影响，并进行沟通/及时上报
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.
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.
Key Accountabilities:
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., Clue Points 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.
- Maintain a positive, results orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the HPC values.
- Work with team members to meet project goals and encourage the support of team members where required.
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study.
- Refresh technologies for each review cycle per DS Plan
- 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 PL 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 Clue Points Issue Management system (links to VV for any on-site interventions required).
- Complete, share, and file Central Monitoring Report.
- All other duties as assigned by management.
Skills:
- Comprehensive knowledge of Parexel RBQM processes and data surveillance methods
- Familiarity with centralized monitoring and Data Driven Monitoring practices
- Proficient in data analysis, trend identification, and issue triage
- Basic understanding of SDTM domains and data operations concepts
- Basic SAS programming skills
- Proficient in relevant software: CTMS, EDMS, MS Office, and Parexel-specific technologies
- 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
Knowledge and Experience:
- 2 or more years of relevant medical, clinical or data management work experience recommended
- Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended.
- Basic SAS programming and/or SQL script writing required
Education:
· Educated to a degree level (medical, biological science, pharmacy and/or data analytics, preferred) or relevant clinical, technology or business equivalent
Originally posted on Himalayas