公司部门:北京诺诚 - Clinical Development - Data Management - 数据管理副经理
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.
10.Qualified individual, with minimum supervision, be able to conduct daily work according to roles and responsibilities as described above.
1.At Least 3 years’ DM experience.
2.Experience Clinical Data Management practices and relational database management software systems. Demonstrated staff leadership skills
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.
6. BA/BS in the biological sciences or related disciplines in the natural science/health care field. Moderate clinical data management experience or an equivalent combination of education and experience.
7.Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
8.Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.