Position Description:
The DM & BS Associate is responsible to proceed data management activities to ensure accuracy and consistency of clinical data for subsequent analysis and reporting. The main responsibility is played as DMS (Data Management Staff) of assigned projects, who should develop plans proactively and executing accordingly, which includes the utilization of EDC system and other clinical data applications to control the process and quality of clinical data to meet the GCPs, SOPs, and related regulatory. A co-DMS will work closely with lead DMS to complete parts of data management activities per lead DMS's assignment. Staff in this position may also have to act as Database Developer, Biostatistician, Programmer when assigned.
Responsibilities:
1. Design Case Report Form (CRF) / electronic Case Report Form (eCRF) and Diary Card
2. Develop Data Management Plan (DMP)
3. Defined Annotated Case Report Form (ACRF)
4. Develope Data Validation Plan (DVP)
5. Prepare SAS program of Data Validation Plan (DVP)
6. Perform visual check on SAS program of Data Validation Plan (DVP)
7. Develop Case Report Form (CRF) Completion Guideline
8. Provide project-specific Electronic Data Capture (EDC) System Training
9. Perform data clean and query process
10. Prepare / review data listings
11. Prepare for database lock
12. Quality Control data for electronic Case Report Form (eCRF)
13. Project related document and data archiving
14. Other responsibilities for Data QC Staff and Data Management Staff defined in the DM SOP
15. Play as Database Developer / SAS programmer / Biostatistician as assigned
16. The lead DMS of a project is responsible for communicating / negotiating with project team and/or sponsor.
17. The lead DMS is responsible to secure the timeline and quality of data management tasks.
18. Assist any department level operation.