临床研究数据助理经理
Clinical Research Data Associate Manager
工作灵活性：远程
Stryker 正在招聘一名临床研究数据助理经理，任职于我们的外周血管业务部门，负责复杂且高可见度的临床研究和项目的临床数据管理工作。该职位对整个研究生命周期中的数据管理活动提供战略监督，确保交付高质量、可靠且符合监管要求的临床数据。助理数据经理是临床数据管理领域的专家，与跨职能利益相关者合作，制定数据收集策略，推动运营卓越，管理供应商，并降低研究风险。该职位独立领导多个研究的数据管理工作，同时参与部门计划、流程改进、标准制定以及指导初级团队成员。
你将负责
- 在整个研究生命周期中领导临床数据管理工作，包括数据库规划、数据审查、问题管理、数据库冻结/锁定准备、研究报告和研究结束工作。
- 设计、构建和维护符合方案要求和研究目标的临床数据库、CRF/eCRF、工作流程、编辑检查和数据收集流程。
- 制定并执行数据管理计划、审查策略、时间表和文档，以确保数据完整性、质量、合规性和检查准备。
- 建立并监控关键研究里程碑，包括数据库上线、中期分析、数据库冻结、数据库锁定、数据传输和归档工作。
- 通过识别趋势、管理问题、调查差异并实施纠正措施，领导数据清理、审查和问题解决工作，以确保准确可靠的研究数据。
- 与跨职能利益相关者合作，包括临床运营、临床洞察、安全、生物统计、编程和法规事务，以支持研究执行、报告、监管提交和数据驱动的决策。
- 支持数据库验证、用户验收测试（UAT）、变更控制活动和持续改进计划，以提升数据管理流程、标准和系统性能。
- 生成数据报告、指标、仪表板和研究总结；为研究人员和数据管理团队成员提供培训、指导和监督，以促进一致的数据质量实践。
查看英文原文
Work Flexibility: RemoteStryker is hiring an Clinical Research Data Associate Manager in our Peripheral Vascular business to serve as the clinical data management lead for complex, high-visibility clinical studies and programs. This role provides strategic oversight of data management activities across the study lifecycle, ensuring the delivery of high-quality, reliable, and regulatory-compliant clinical data. The Associate Data Manager is recognized as a subject matter expert in clinical data management and partners with cross-functional stakeholders to develop data collection strategies, drive operational excellence, manage vendors, and mitigate study risks. The position independently leads data management activities for multiple studies while contributing to departmental initiatives, process improvements, standards development, and mentoring junior team members.
What you will do
- Lead clinical data management activities across the study lifecycle, including database planning, data review, query management, database freeze/lock readiness, study reporting, and study closeout activities.
- Design, build, and maintain clinical databases, CRFs/eCRFs, workflows, edit checks, and data collection processes aligned with protocol requirements and study objectives.
- Develop and execute data management plans, review strategies, timelines, and documentation to ensure data integrity, quality, compliance, and inspection readiness.
- Establish and monitor key study milestones, including database go-live, interim analyses, database freezes, database lock, data transfers, and archival activities.
- Lead data cleaning, review, and issue resolution activities by identifying trends, managing queries, investigating discrepancies, and implementing corrective actions to ensure accurate and reliable study data.
- Collaborate with cross-functional stakeholders, including Clinical Operations, Clinical Insights, Safety, Biostatistics, Programming, and Regulatory Affairs, to support study execution, reporting, regulatory submissions, and data-driven decision making.
- Support database validation, user acceptance testing (UAT), change control activities, and continuous improvement initiatives to enhance data management processes, standards, and system performance.
- Generate data reports, metrics, dashboards, and study summaries; provide training, guidance, and oversight to study personnel and data management team members to promote consistent data quality practices.
What you need
Required Qualifications
- Bachelor’s degree
- Minimum of 6+ years of clinical data management experience supporting clinical trials in the medical device, medical technology, or pharmaceutical industry.
- Experience leading or contributing to departmental initiatives, strategic planning efforts, or organizational improvement projects.
- Demonstrated experience independently leading data management activities across multiple complex clinical studies.
Preferred Qualifications
· Experience leading end-to-end clinical data management activities across multiple studies and throughout the study lifecycle.
· Advanced experience with CRF/eCRF design, clinical database development, edit check specification, validation, and UAT.
· Proficiency with SQL and/or other data review and reporting tools used to identify trends, data quality issues, and opportunities for process improvement.
United States of America Pay Ranges:
- USN: $110,100 - $183,400 USD Annual
- US5: $115,600 - $192,600 USD Annual
- US10: $121,100 - $201,700 USD Annual
- US15: $126,600 - $210,900 USD Annual
- US20: $132,100 - $220,100 USD Annual
- US30: $143,100 - $238,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Originally posted on Himalayas