Description
The Database Programmer is responsible for all technical aspects of study build, validation, and maintenance, including clinical programming activities for new and ongoing clinical studies, start-up activities, database revisions, timely resolution of technical issues related to the conduct and closeout of clinical studies. Database Programmer works collaboratively with sponsors and multiple functional groups to complete programming tasks per agreed upon timelines.RESPONSIBILITIES AND REQUISITE SKILLS:
- Serve as a primary technical point of contact for assigned studies
- Program/configure eCRFs, edit checks, derivations, custom functions, and reports
- Perform and coordinate validation and testing, including Unit Testing and UAT
- Develop annotated case report forms
- Complete database upgrades and migrations
- Design, review, and maintain electronic data transfer and integration specifications
- Maintain appropriate technical and study documentation
- Facilitate integration with other tools, perform data extracts and batch uploading
- Program and generate data listings in support of data review
- Review database, edit check, integration, and report specifications and provide input
- Ensure compliance with applicable regulatory requirements for data capture and storage, company SOPs and study specific procedures
- Understand and apply System Development Lifecycle (SDLC) practices
Must have a Bachelor's degree and 5 years of experience in database design and edit check programming utilizing Medidata RAVE.
Experience in SAS, JReview, and C# is preferred.