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Manager, Clinical Database Development
Company | Regeneron |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-08-19 |
Posted at | 11 months ago |
The Manager, Clinical Database Developer works with the Study Data Manager and study team members to develop clinical database using Medidata’s Rave EDC system to meet First Patient First Visit timeline and to maintain and update the database as needed. You will ensure implementation of Regeneron standards in clinical database during the startup and the study conduct. Support EDC data transfer, data snapshot, database lock and post data lock subject data archival processes.
- Participate and lead Clinical Database Development team meetings when needed.
- Set up Clinical Views as required, contribute to the creation of CDASH compliant eCRFs, maintain and contribute to company Standard Global Library.
- Work with Clinical Study Team through Study Data Manager to implement comprehensive eCRF system in Rave Architect using the Global CRF Library, reuse of prior studies, and new unique CRFs.
- Maintain eCRF system for the duration of the study. Perform change control by defining any eCRF Change Requirement including CRF updates due to protocol amendments, clarifications, and postproduction issues identified by users. Document change control requirements, version updates, UAT and migration testing.
- Be responsible for the URL Core Configuration and iMedidata admin., while managing the needs of our CRO partners using the URL Core Configuration.
- Facilitate UAT process - build UAT site and publish EDC system in UAT environment, invite Regeneron and CRO UAT participants via iMedidata. Resolve reported issues for the duration of UAT until system is deemed ready for launch.
- Ensure launch of Rave EDC system in a timely manner prior to first subject first visit with full testing completed. Ensure proper documentation and approval of specifications and testing.
- When applicable, configure additional Medidata applications including but not limited to Coder and TSDV for use on study.
- Control user access to database at study owner level
- Act as a primary contact to data management team for assigned studies to provide all necessary technical support and to ensure quality programming standards
- Support Regeneron Secure Data Transfer system by managing access requests; user admin; user accounts and file structure.
- Assist with the creation of standard and custom reports in EDC using relevant report tools such as clinical reporting and business object tools.
- Assist Manager to: Support/develop and maintain SOPs related to EDC build process.
- When applicable, work with vendor on EDC and 3rd party system integration and perform external data loads as applicable, i.e., IxRS, labs, ECGs, etc.
- Define data validation requirements including edit checks, dynamics, derivations and custom functions. Program data validations in Rave Architect, including edit checks, dynamics derivations and custom functions prior to completion of eCRF build. For sophisticated and new custom functions, work with Medidata to be responsible for Medidata programming and testing of custom functions.
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