Develop and maintain trial specific database applications, including eCRFs and database specifications, program validation and derivation procedures within the clinical database management (such as OC / RDC, Inform, Rave) using relevant programming languages (SQL, PL / SQL, C #, VB script, SAS) system in support of in-
house and outsourced trials globally, of various levels of complexity for Phase I-IV independently or with minimal supervision.
Support a special project of limited scope (sub team lead, local project, etc.) both clinical and non-clinical in nature.
Provide study level expertise and involvement in CTTs.
Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.
Create, test and maintain trial specific plausibility and consistency checks.
Provide data transfer specifications for third party data.
Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes.
Develop database specifications and provide support for outsourced trials.
Create, file and maintain appropriate trial documentation.
Program and test procedures, of various levels of complexity, according to documented trial specific requirements, within the clinical database management system using relevant SQL, PL / SQL, C#, VB script,SAS
Maintain and update procedures as required for protocol amendments or required post production changes.
Creation and Execution of trial design reports based on trial metadata.
Good knowledge of Novartis Clinical Data Standards. Understanding of Data Models and implementation for database development.
Act as a trainer / mentor to new or less experienced associates on specific task(s).
Contribute in the development and maintenance of project specific libraries.
University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree Fluent English (Oral and Written) At least 3 years’ experience in clinical database programming, setup of clinical databases and CRF design, and procedure / validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following :