The Senior 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 during the study conduct. They ensure implementation of Regeneron standards in clinical database during the startup and the study conduct.
In this role, a typical day might include the following:
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 outstanding CRFs.
Define data validation requirements including edit checks, dynamics, derivations and custom functions. For complex and new custom functions, work with Medidata to coordinate Medidata programming and testing of custom functions.
Facilitate UAT process - create 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 go-live.
Set up Clinical Views per company standards, contribute to the creation of CDASH compliant eCRFs, maintain and contribute to company Standard Global Library.
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.
Ensure release 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.
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 post-production issues identified by users. Document change control requirements, version updates, UAT and migration testing.
This role may be for you if you have experience:
Participate and lead Clinical Database Development team meetings when needed.
Support Regeneron Secure Data Transfer system by leading access requests; user admin; user accounts and file structure.
Be responsible for the URL Core Configuration and iMedidata admin., while owning the needs of our CRO partners using the URL Core Configuration.
To be considered for this opportunity you will need:
Bachelor Degree in Mathematics, Science or a related field
4+ years of experience within combined direct and indirect Rave EDC database development experience
2 years of hands-on developing EDC database for up to late phase clinical studies.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)