资深经理，临床数据管理
Manager Clinical Data Management
管理员，临床数据管理负责管理临床数据团队处理项目管理文件，预先执行 EDETEK 的 CONFORM eClinical 临床数据控制活动和系统实施，为该系统编写设计规格 （表单，报告等）,并促进系统实现测试。除了与临床数据处理操作和活动保持亲密关系外，临床信息管理经理监督数据管理项目以确保质量，及时交付和持续客户满意度；确定客户需求并开发创新解决方案，利用专业知识，运营能力和技术；与客户和内部团队沟通。临床数据管理经理应充分了解良好的临床数据处理服务的要求，包括其文件；参与公司内部和客户特定数据管理项目的启动或完成；对相关治疗指标，研究假设和试验设计有理解；并对数据库设计和结构有深刻的认识。重要功能·支持内部临床数据控制倡议 · 完成传统和分配数据管理操作/活动 ·通过与客户沟通有关需求和问题，利用专业知识，执行标准运营程序，监测项目进展和时间表，协助开发和维护用于支持项目的基础设施的系统。· 与临床数据专家 (CDS) 合作执行数据管理计划。·根据需要领导与客户/赞助商进行通信，以提供合同的临床数据管理服务和高质量和完整性的临床资料。·确保按 EDETEK 和项目要求提交所有所需文件。·对新软件进行领先使用接受检验 (UAT). · 选择和采访临床数据管理人员的候选人 ·培训和指导年轻团队成员 · 亲自，电话或书面有效地以英语语言沟通的能力。· 领导功能会议的能力。· 对细节和准确性有着强烈关注能力。· 优秀的组织技能。· 多项项目管理能力；· 在多个组织结构中协同，有效和生产力工作的能力。· 自主工作，倡议和行动的能力。
查看英文原文
Manager, Clinical Data Management leads clinical data management team to handle project management documentation, preform clinical data management activities and system implementations for EDETEKâs CONFORM eClinical, write design specifications for the system (forms, reports, etc.), and facilitate testing of system implementations. In addition to stay hands-on with clinical data management operations and activities, Manager of Clinical Data Management oversees data management projects to ensure quality, timely delivery and ongoing client satisfaction; identifies client needs and develops creative solutions for projects, leveraging expertise, operational capabilities and technologies; communicates with clients and internal teams.
The Manager, Clinical Data Management should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
ESSENTIAL FUNCTIONS· Support internal clinical data management initiatives
· Complete traditional and assigned data management operations/activities
· Contribute to project success by communicating with clients about requirements and issues, leveraging expertise, enforcing standard operation procedures, monitoring project progress and timelines.
· Assist in the development and maintenance of systems used to support project infrastructure
· Work with Clinical Data Specialists (CDSs) to execute Data Management Plans
· Lead the communication with clients/sponsors as necessary to deliver contracted clinical data management services and clinical data with high quality and integrity
· Ensure filing of all required documentation per EDETEK and project requirements
· Lead Use Acceptance Testing (UAT) on new software
· Select and interview clinical data manager candidates
· Train and guide junior team members
- Ability to communicate effectively in the English language in person, by phone and in writing.
- Ability to lead functional meetings
- Strong attention to detail and accuracy is a must
- Excellent organizational skills
- Demonstrated ability to manage multiple projects
- Ability to work collaboratively, effectively, and productively in diverse organization structures.
- Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication
- Ability to work in a team-oriented, collaborative environment.
- Ability to work positively within a continually changing environment.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Advanced computer skills and practical knowledge of MS Office and potentially project management software.
- A Bachelorâs degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred.
- A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required.
- Prior trial responsibility for the entire data management life-cycle is desirable.
- Working knowledge of EDC studies and SAS is required.
- Corporate office environment.
- Some travel (5%) may be required with a potential of travel occurring over weekends.
- Cross-functional interactions
Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.
· Choice of comprehensive Medical, Vision and Dental Insurance plans
· Paid vacation time and sick days
· Corporate holidays annually
· Participation in the 401K Plan
· Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
· Health Advocate and Employee Assistance Program
LocationThis is a remote position, and we are open to candidates based in the United States.
Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individualâs race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.Â
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