
工作职责:
数据管理:
1. Be responsible for Data Management (DM) operational tasks include but not limit to DMP (DM Plan), CRF (Case Report Form) design, CRF completion guideline, edit check specification, data cleaning, medical coding, SAE (Serious Adverse Event) reconciliation etc.
2. Collaborate with DM manager, DM team member and study team member.
3. Compliance with GCP, regulations, company and/or sponsor SOPs. Ensure inspection readiness.
SAS 编程:
1. Be responsible for study level DM SAS programming and testing in clinical trials.
2. Develop DM documents include but not limited eCRF, Edit Check Specification, Data Transfer Agreement, SDTM documents and so on following SOPs
3. Develop SAS program for non-EDC edit checks, listings for data review, external data integration and reconciliation etc.
4. Create SDTM aCRF, Mapping Specification, metadata, SDRG etc. for SDTM package. Develop SAS program for SDTM package and QC of SDTM package
5. SAS macro development
数据库:
1. Be responsible for study level EDC (Electronic Data Capture) development in clinical trials.
2. Develop DM documents include but not limited eCRF, Edit Check Specification etc. following SOPs
3. EDC system development: eCRF design, Edit check development, system setting, report development etc.
4. EDC macro development
5. Work on one or more EDC platform
6. Build and maintain metadata repository
7. Create and/or review related documents
任职资格:
1. Education: Bachelor or Master Degree in Biostatistics, Statistics, Epidemiology, Mathematics, or Computer Science other scientific field (or equivalent theoretical/technical depth).
2. Good communication skill
3. Excellent in Oral and writing English