临床数据管理PDM/SCDA/CDA-北京

公司部门: 诺诚健华

工作地点:南京

发布日期:2022-07-25

招聘人数:1人

职位类型:其他

职位描述:

1. 审核并指导CRO DM起草的文件:

a. 数据管理计划;

b.病例报告表开发规范;

c. 外部数据一致性核查计划;

d. 严重不良事件一致性核查指南;

e. 质量计划以及其他授权撰写或需求的计划;

2. 日常管理临床试验中数据管理的相关文件,确保所有文件及时更新。

3. 对CRO DM在数据冻结和锁定的操作和流程进行监管。

4. 确保所有文件和数据库(数据集)从CRO DM传输回公司并进行适当的归档。

5. 确保和监管CRO DM的交付质量,包括:根据用户测试计划制定的,用于数据录入的用户测试、系统逻辑核查、数据列表、导入/导出程序和医疗编码。

6. 监管CRO DM的执行安排,并要求CRF/eCRF数据库和其他相关数据库之间的数据传输/导入/导出。

7. 审核并审批:

a. 数据验证、电子数据交换、编码、CRF/eCRF电子界面设计、数据库设计、用户测试、CRF追踪、CRF/eCRF完成和其他授权/要求的适用项目计划的项目计划和指南;

b. CRF数据库和外部数据清单和摘要(统计报告要求的除外)的规范;

c. CRF数据库和外部数据清单和摘要(统计报告要求的除外)的输出结果。

8. 培训和指导初级数据管理人员。

9. 通过定期培训保持数据管理系统和流程的专业水平。能够抓住机会在项目上与其他同事建立良好的关系。

1. Review and provide guidance to files drafted by CRO DM:

a. Data Management Plans;

b. CRF Development Spec

c. External Data Reconciliation Plan

d. SAE Reconciliation Guidelines;

e. Quality Plans; and other plans as delegated/required.

2. Manage study DM documentation on an ongoing basis and ensures that all filing is up to date.

3. Oversight CRO DM on database freeze and lock processes and procedures.

4. Ensures that all applicable documents and databases (data sets) are archived or returned to the company from CRO DM appropriately.

5. Ensures and Oversight CRO DM deliverable quality includes: user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.

6. Oversight CRO DM to perform Schedules and requests data transfers/imports/exports to/from CRF/eCRF database and associated databases.

7. Reviews and approves:

a. project plans and guidelines for data validation, electronic data interchange, coding, CRF/eCRF screen, database design, user testing, CRF tracking, CRF/eCRF completion and other applicable project plans as delegated/required;

b. specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources;

c. output from listings and summaries (other than for statistical reporting requirements) from CRF databases, and external data sources.

8. Trains and mentors data management staff.

9. Maintains proficiency in Data Management systems and processes through regular training. Takes the opportunity to network with colleagues for new studies.

任职条件:

1. 至少3年的数据管理经验。

2. 具有临床数据管理实践和相关数据库管理软件系统的经验。具有一定的领导力。

3. 直接接触过Oracle Clinical、Rave或Inform系统。具备医学术语、临床数据和ICH/GCP的相关知识。

4. 精通MS Windows、Word、Excel、PowerPoint和电子邮件等应用程序。

5. 具备良好的口头和书面沟通技巧。良好的组织、计划和时间管理能力,能够在紧迫的期限内完成多项任务,并能同时注意细节。

1. At Least 3 years’ DM experience.

2. Experience Clinical Data Management practices and relational database management software systems.

3. Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.

4. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.

5. Effective oral and written communication skills. Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.

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