Associate Clinical Database Developer

Job description

Job Description

Develop and maintain trial specific database applications, including eCRFs and database specifications, in support of in house and outsourced trials and Program validation and derivation procedures of low to medium complexity within the clinical database management system (such as OC/RDC, Inform, Rave) using relevant programming languages (SQL, PL/SQL, C #, VB script, SAS) to support the development of trial specific database applications globally for Phase I-IV with supervision.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 procedures of low to medium complexity from documented trial specific requirements, within the clinical database system using SQL, PL/SQL, C#, VB script,SAS. § Maintain and update procedures as required for protocol amendments or required post production changes. § Execution of trial design reports based on trial metadata. § Understanding of Novartis Clinical Data Standards.Quality and timeliness of deliverables § Revisions to deliverables caused by Database Developer errors.

Desired profile

University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree Fluent English (Oral and Written) At least 6 months to 2 years of 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: • Basic knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS) • OC/RDC or INFORM experience preferred • Basic understanding of clinical data management systems and/or relational databases as applied to clinical trials • Attention to detail, quality, time management and customer focus • Ability to translate technical concepts for non-technical users in the areas of clinical database design and procedure development • Strong verbal and written communication skills to work with our global partners and customers. • Basic understanding of Drug Development Process, ICH-GCP and Health Authority guidelines and regulations