临床数据经理 (合同制)
Clinical Data Manager (Contract)
eClinical Solutions 通过专业的数据服务和 elluminate 临床数据云——数字试验的基础，帮助全球生命科学组织加速临床开发项目。elluminate 平台和数字数据服务使客户能够从一个集中位置自助访问所有数据，并提供高级分析功能，帮助他们做出更明智、更快的商业决策。
eClinical Solutions 致力于通过更好的数据管理和数据分析方法推动临床试验的创新。我们使用 eClinical Solutions 技术平台 elluminate 贯穿整个数据管理流程，以加快客户的进度并自动化手动流程。我们认为，利用核心技术 elluminate 可以采用更敏捷的数据管理方式，使我们的生命科学客户能够主动管理其临床项目并做出决策。
您将产生影响：
有经验的临床数据经理，具备在整个数据生命周期中审查和报告临床数据的专业技能。在遵循行业标准和监管要求的前提下，有开发全面研究文档、设计、实施和管理从启动到收尾的数据交付物的显著成果。擅长在临床运营、生物统计和编程团队之间促进协作，整合数据管理活动并提高运营效率。致力于持续改进，了解新兴技术和行业趋势，以实施有效的数据管理最佳实践。
在一个快速发展的公司中提升技能和职业发展，同时影响医疗健康的未来。
您的日常职责：
· 作为 eClinical Solutions 主要 DM 代表和支持人员，负责与客户数据管理互动，确保 eClinical Solutions 数据管理流程得到遵循，交付物符合质量和时间表要求并在批准范围内
· 提供研究需求，包括方案转换、数据库构建、CRF 设计、数据录入、数据验证、数据审查、查询管理
· 定义规格并与技术团队合作，配置 elluminate 用于数据清理策略和监督活动
· 对团队成员开发的交付物进行质量控制，包括研究文档、程序和报告规格、交付物和 elluminate 模块
查看英文原文
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.
You will make an impact:
Experienced Clinical Data Manager with expertise in the review and reporting of clinical data throughout the entire data lifecycle. Proven track record of developing comprehensive study documentation, designing, implementing, and managing data deliverables from start-up to closeout in adherence to industry standards and regulatory requirements. Skilled in fostering collaboration among clinical operations, biostatistics, and programming teams to integrate data management activities and enhance operational efficiency. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
· Acts as support for primary DM representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope
· Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
· Define specifications and collaborate with technical team on configuration of elluminate for data cleaning strategy and oversight activities
· Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate modules
· Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks, and develop mitigation strategies
· Monitor and interpret key performance indicators (KPIs), metrics, dashboards, and reports for process and efficiency improvement
· Other duties as assigned
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
- 5+ years’ experience in Clinical Data Management preferred
- Bachelor’s degree in a health-related field or equivalent experience preferred
- CCDM Certification preferred
- Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
- Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
- Strong analytical and strategic thinking skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent collaborative skills
- Demonstrated command of the English language with proficiency in both verbal and written communication
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
- Proficient with EDC and Clinical Data Management Systems
- Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred
- Experience with RBQM methodology preferred
- Exposure to CDISC guidelines and standards
AI Use Statement
Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here:
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
Pay Range
US Pay Ranges
$90,000—$110,000 USD
Originally posted on Himalayas