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. 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.
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 unique CRFs.
- 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.
- 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.
- Set up Clinical Views as required, 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.
- When applicable, configure additional Medidata applications including but not limited to Coder and TSDV for use on study.
- 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.
- 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.
- Control user access to database at study owner level
- Assist with the creation of standard and custom reports in EDC using relevant report tools such as clinical reporting and business object tools.
- Act as a primary contact to data management team for assigned studies to provide all necessary technical support and to ensure quality programmig standards
- Assist Manager to: Support/develop and maintain SOPs related to EDC build process.
- Participate and lead Clinical Database Development team meetings when needed.
- Support Regeneron Secure Data Transfer system by managing access requests; user admin; user accounts and file structure.
- Be responsible for the URL Core Configuration and iMedidata admin., while managing theneeds of our CRO partners using the URL Core Configuration.
To Be Considered: Requires BS/BA in Math, Science or related field. 4 or more years of combined direct and indirect Rave EDC database development experience. At least 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)
$92,500.00 - $150,900.00