职位描述：
Main Tasks:
Review & comment on protocols, especially with focus on standardization of data collection, use of Case Report Form standard modules.
Supervise the set-up of CRF to ensure that contents, composition and design confirm with the respective protocol, the project standard and all applicable SOPs.
Co-ordinate the set-up, formatting, sending and receipt of electronic data with laboratories (CDP trials).
Set up database in Oracle Clinical for local and CDP trials.
Create annotation, TVP, TDP and editing validation and derivation programs.
Perform query management and DCFs generation and tracking.
Generate trial documentation such as Data handling protocol/Report and Raw Data Listings, organize database release meeting.
Prepare related documentations for statistical analysis and clinical trial report.
Contribute to reports including clinical reports in the form of listings based on raw data in collaboration with trial members.
Make out electronic data tracking and data extracting method.
Organize, plan and schedule his/her own participation in projects. Plan, co-ordinate, supervise and evaluate the DM activities for local clinical trials and CDP trials.
Bring to the attention of the DM alternative/additional tools, facilities, methods, techniques.
Contribute to generation of a co-operation and collegial atmosphere within the trial team and department.
Perform Data coding with WhoDrug and MedDRA dictionary in TMS system.
Qualifications:
Bachelor's degree is required, preferably in biomedical related field or computer related field.
In-depth knowledge of the data management process.
Computer proficiency required; familiar with SQL language, Programming skills of database software, i.e. Oracle, SAS, or Access required.
Comprehensive knowledge of the structure of database.
Excellent spoken and written English.
2-3 years working experience in Data management work, preferable in the field of relation database system. |