临床试验首席数据经理
Lead Data Manager for Clinical Trials
我们全球有超过2700名员工。我们是科学家、策略师、创意人员和创新者。我们重视个人的卓越表现，并在所有业务中建立强大的团队合作基础。我们热爱行业的挑战。我们每一步都在改变生活，重新定义成功。
高级数据经理将负责在一般监督下进行大型复杂研究的所有数据管理活动，或在小到中型项目的数据管理活动中，在最少监督下进行工作。
沟通
· 项目团队和公司部门在临床数据管理方面的主要沟通点
· 客户/供应商在临床项目和临床数据管理报告方面的沟通渠道
数据管理
· 协调与EDC开发、数据收集、清理、核对、数据库锁定、最终集成数据库的开发以及最终数据管理交付物生成相关的临床项目中的数据管理活动。
· 负责临床项目中的临床数据管理活动，包括但不限于：
· 研究文件审查
· 数据管理计划和其他项目特定指南和说明的开发和审查
· 协调/执行用户验收测试
· 数据验证计划/编辑检查规范的开发
· 数据录入的协调和监督，向数据录入人员提供关于数据录入质量和其它数据录入问题的反馈
· 数据验证，包括自动和手动数据检查、数据差异/缺陷的审查和解决、查询的生成和解决，并向临床试验团队提供关于数据质量的反馈
· 非CRF电子数据处理（接收、归档、加载到研究数据库、审查和解决核对问题，并向供应商提供关于数据质量和其它问题的反馈）
· 数据库编辑（纸质CRF研究）
· 手动CRF审查（非医学检查）
· 临床数据库锁定
· 协调和监督CRF/查询的处理、分发和归档
- 参与CRF和其他数据收集表的设计；审查病例报告表设计的准确性和对方案的遵循情况
- 开发CRF填写指南
- 使用编码词典和编码清单对医疗数据进行编码（具有医学/生物学背景的高级数据经理，需额外培训）
- SAE核对
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We’re over 2,700+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.
The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.
Communication
· Primary communication point for project teams and company departments with regard to clinical data management
· Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
Data Management
· Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
· Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:· Study documents review
· Data Management plan and other project-specific guidelines and instructions development and review
· Co-ordinate/perform user acceptance testing
· Development of Data Validation Plan/Edit Check Specifications
· Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
· Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
· Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
· Database edits (paper CRF studies)
· Manual CRF review (non-medical checks)
· Clinical database lock
· Coordination and supervision of processing, dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
- SAE reconciliation
- Electronic data transfer (import/export) specifications review and approval
- Document Management
- Liaison with Document Center with regard to maintenance of TMF and eTMF
- Quality Control
- Database QC checks performance and documentation
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
- Training
- Training of Assistant Data Managers
- Project-specific training of investigators and clinical team in CRF completion
- Corporate/Departmental Assignments
- Investigator Meetings preparation/attendance
- Meetings and teleconferences organized by client/vendor preparation/attendance
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
- At least 3 years of experience of full scope of data management responsibilities in international EDC studies
- At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
- Project data management experience is a plus
- Full working proficiency in English
- Organizational and managerial skills
Advance your career in clinical research and develop new skillsets whilst growing with the organization.