临床数据经理
Clinical Data Manager
一个令人兴奋的机会加入Veramed的数据管理业务部门！随着我们持续增长并建立在成功的基础上，我们正在寻找一位充满热情且有驱动力的临床数据经理。您需要具备扎实且深入的数据管理研究启动经验，熟悉Medidata Rave（包括eCOA），并具有供应商管理经验。该职位可在我们的英国办公室工作，或采用混合办公模式。
Veramed以两个关键领域为傲：为客户提供最高质量的数据管理、统计和编程咨询服务，并为员工提供行业领先的办公环境，支持其职业发展和培训。
**职责：**
临床数据经理的职责是为数据管理部门在多个项目、赞助商和治疗领域提供数据管理支持。提供专业知识并管理新数据管理研究的启动。
**主要职责：**
以下列出的工作任务概述了该职位的范围。根据当前业务需求，这些任务的应用可能会有所不同。
**技术方面：**
- 审查临床方案
- 创建或审查用于数据收集的病例报告表，并与方案进行比较以确保一致性
- 创建或审查编辑检查规范文档
- 准备用户验收测试（UAT）文档并执行EDC的UAT，传达发现结果
- 创建特定研究的文档，如数据管理计划、数据审查计划、电子CRF填写指南等
- 创建或审查数据审查列表和/或定制报告的规范，以促进数据清理
- 持续审查EDC中输入的数据，以确保数据适合分析
- 根据需要向临床监查员或研究现场提出问题
- 解决标准问题
- 执行医学编码
- 与外部供应商合作处理数据传输协议/规范
- 确保所需的外部数据得到核对
- 跟踪问题和数据清理活动，以确保已完成数据输入的持续审查，数据适合分析
- 维护研究主文件文档以及任何其他需要随时接受审计的文档
- 按照内部（或赞助商，如适用）的标准操作程序和流程工作
**项目管理：**
- 可能作为赞助商的主要联系人
- 了解研究预算并主动识别范围变更
- 确保关键项目里程碑按时交付，保证最高质量
查看英文原文
An exciting opportunity to join Veramed's Data Management Business Unit! As we continue to grow and build on our success, we're looking to recruit a passionate and driven Clinical Data Manager. You'll be required to have strong and in-depth experience of Data Management Study Start Up, Medidata Rave (including eCOA) and experience of vendor management. This role can be based in our UK offices or a hybrid working model.
Veramed prides itself on two key areas: providing the highest quality Data Management, Statistics and Programming consultancy for its clients, and giving its employees an industry leading working environment with support and training for career growth.
**Purpose:**
The role of the Clinical Data Manager is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. Provide expertise and manage the start up of new data management studies.
**Key Responsibilities:**
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
**Technical:**
- Review of clinical protocols
- Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
- Create or review Edit Check Specification document
- Preparation of UAT documentation and perform UAT of EDC and communication of findings
- Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
- Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
- Ongoing review of data entered in EDC to ensure the data is clean for analysis
- Issue queries to clinical monitors or investigational sites as appropriate
- Resolve standard queries
- Perform medical coding
- Work with external vendors on data transfer agreements / specifications
- Ensure external data is reconciled as required
- Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
- Maintain study master file documents and any other documents that are required to be audit ready
- Work in accordance with internal (or sponsor, where applicable) SOPs and procedures
**Project Management:**
- May serve as the main contact for the sponsor
- Awareness of study budget and proactive identification of scope changes
- Ensure key project milestones are delivered on time with the highest quality
- Maintain timelines and communicate risks / updates to the Data Management Project Manager
- Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality
**General:**
- Lead internal and client study team meetings effectively
- Present study updates internally and at sponsor meetings
- Share scientific, technical and practical knowledge within the team and with colleagues
- Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
- Build effective collaborative working relationships with internal and sponsor team members
- Seek opportunities to develop innovative ideas and sharing when appropriate
- Mentorship of more junior team members
- Contribution to development of internal training materials
- Contribution to internal process improvement initiatives
**Minimum Qualification Requirements**
- BSc or MSc in numerical discipline (or relevant equivalent industry experience).
- At least 4-5 years of relevant industry experience.
- Understanding of clinical drug development process, relevant disease areas, endpoints, and different study designs
- Awareness of industry and project standards & ICH guidelines
- Excellent verbal and written communication skills
- Interpersonal/teamwork skills for effective interactions
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables
- Demonstrated problem solving ability and attention to detail
- Project leadership experience
- Ability to make informed and appropriate decisions
**_Veramed is a B Corp_** _accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability._
_As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment._