OmniComm Systems, Inc. is a fast-growing, global eClinical software and services company dedicated to helping the world’s pharmaceutical, biotechnology and medical device manufacturers to maximize the value of their clinical research investments through the use of innovative software and progressive technologies. OmniComm Transformation Services helps organizations transform their clinical business through innovation, integration, and process optimization activities. OmniComm Transformation Services is seeking outstanding individuals with versatile professional services and technology backgrounds, a passion for delivery excellence, and a track record of success.
The Clinical Data Developer is a strong technical individual with clinical programming, clinical software, and SQL Server and/or ETL database skills. The Clinical Data Developer is responsible for developing scripts used for updating databases, transforming data, migrating data, importing and exporting data, creating reports, and integrating applications. This individual will develop scripts using SQL-Server databases, SQL programming, SQL Server Reporting Services (SSRS), SAS and other scripting, reporting and data transformation tools.
The Clinical Data Developer posesses broad technology and clinical systems skills including an understanding of application and database architectures, and other software components. The ideal candidate for the Clincal Data Developer role has an excellent work ethic, commitment to high quality standards, attention to detail, ability to work in a very fast-paced, collaborative, collegial, multi-disciplinary environment, and a passion for quality and delivery excellence.
The Clinical Data Developer creates SQL and/or SAS scripts used to update customers clinical study data and migrate data across platforms or environments. The Clinical Data Developer develops SQL and/or SAS scripts to customize data imports or exports, and to help troubleshoot and/or repair data issues or problems The Clinical Data Developer provides custom reports or data outputs to customers using SSRS, Logi Analytics, XML output, and other reporting tools. The Clinical Data Developer performs data transformations using SQL Server Integration Services (SSIS) The Clinical Data Developer will learn the OmniConnect™ Web Service API interface, and will help support customers in the use of this tool using programming languages such as Java and/or C Sharp. The Clinical Data Developer performs unit testing and system testing on all scripts to be used in production. The Clinical Data Developer maintains proper documentation to ensure compliant standards are met according to company SOPs. The Clinical Data Developer assists in the deployment of clinical software upgrades onto our development, test, training, and production servers.
Experience working with Life Sciences organizations involved in the conduct of clinical trials Knowledge, experience working with Clinical technologies and data such as Electronic Data Capture, Clinical Trials Management Systems, Adverse Events Reporting, and SAS. Working knowledge of SQL Server 2005 or higher - knowledge of SQL Replication, SSIS, and SSRS is highly desirable Experience developing programs using SAS (Statistical Analysis Software) is highly desirable Experience using and ETL tool such as SSIS is desirable. Strong troubleshooting skills with the ability to organize and prioritize multiple simultaneous requests. Strong attention to detail. Ability to work independently in a very fast-paced environment. Familiarity with the software development life cycle and the ability to document result of software deployments and implementations. Understanding the clinical industry standards such as CDISC SDTM, ODM, and MedDRA, WHODRUG, and E2B standards. Strong communications, writing, and analytical skillsets. Understanding of industry methodologies and Microsoft delivery tools. Demonstration of interpersonal skills necessary to maintain positive relationships with clients and all users. Ability to establish priorities, can work independently, and can proceed with objectives without supervision.
College Degree with a major in Information Technology, Computer Science, Biology or similar. Has a strong background with pharmaceutical or clinical data, systems, and processes; strong communication skills, and professionals services / consulting background. Knowledge of industry regulatory and IT standards including computer systems validation, 21 CFR Part 11, CDISC, MedDRA, WHODRUG, E2B, and HL7. 3-5 years of experience with related technology, professional services, and/or life sciences industry expertise
This position will report into OmniComm Systems Solutions Center in Monmouth Junction, NJ.
OmniComm Systems, Inc. provides Web-based Electronic Data Capture (EDC) software and services that streamline the clinical research process....