SDTM Developer (Clinical Data Management)
PSI CRO
- Shanghai
- Permanent
- Full-time
- Communication point for data management and statistics on matters of database programming and deliverable database development
- Clinical database (EDC) requirements/structure review and testing
- Data validation plan review and programming of data validation procedures
- Generation of clinical database listings and reports to support clinical trial data collection, tracking, review and validation
- Programming of patient profiles
- Participate and support the development of Study Data Tabulation Model (SDTM) (define.xml, annotated CRF, reviewer's guide) and programming of data transformation from raw data sources into CDISC-complaint deliverable
- Validation of clinical trial data according to SDTM specifications
- Deliverable database transfer to clients; electronic data transfers
- Liaison with vendors and clients regarding electronic data transfer specifications
- Receipt and validation of electronic data transfers
- College or University degree (IT, programming, technical education)
- Sufficient relevant technical experience
- Experience in Clinical Data Management systems (like Medidata/Veeva) is desirable
- Knowledge of and experience in the SAS programming language (Base SAS, SAS/Macros, SAS/ODS)
- Knowledge of and experience in SQL
- Proficient user of standard MS Office applications and MS Access
- Experience in a professional environment, preferably with clinical or medical data