Position

Clinical Database Analyst

Main Tasks

Review & comment on CRF, especially with focus on standardization of data collection, use of Case Report Form standard modules. Ensure that the CRF modules can be mapped to database and applicable SOPs.
Set up DCM, DCM layout, DCI, DCI book according protocol and CRF for local and CDP trials.
Maintain database; perform database update to in accordance with updated protocol or CRF.
Review and comment on electronic data specification, ensure the lab data format in accordance with related SOPs.
Leading the electronic data loading.
Review and comment on TVP, TDP. Classify the validation to OC procedure, SQL script listing and other methods.
Create and testing validation and derivation procedures in database according TVP, TDP.
Prepare SQL scripts according TVP.
Maintain validation procedures including OC procedure and SQL scripts.
Make out electronic customized data tracking form/reports for TDM to monitoring the trial status. Apply the data extracting method and report to DM process.
Develop and maintain DM web report system.
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..

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.

For application or detailed information,send e-mail to recruit@novonordisk.com