Design and set-up of study database for data collection in clinical trials based on protocol needs
Set up of models and performing transformation updates in DMW
Mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench) / CDW (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Mode deliverables.
Active participation in sharing better practices on use of standards in alignment with Lead Clinical Data Programmer and Process & Automation Specialist.
Maintain system related documentation.
Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards).
Ensure testing is performed and database meets specification requirements before deployed into production and document pass and fail scenarios in a timely manner.
Design, Programming and validate programs to check data accuracy and aid report generation.
Set up of models and performing transformation updates in DMW
Mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench) / CDW (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model) deliverables
Active participation in sharing better practices on use of standards in alignment with Lead Clinical Da-ta Programmer and Process & Automation Specialist
Maintain system related documentation
Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards)
Design, Programming and validate programs to check data accuracy and aid report generation
Experience Required:
Minimum 2-5 years of experience in pharmaceutical industry and preferably 2 years within clinical data management.
Good experience on end-to-end clinical data management activities.
Good knowledge of clinical systems and preferable experience in programming languages (eg: SAS/SQL). Requires basic knowledge on AI & ML to be part automation/innovation initiatives within and across the departments.
