Sr. Clinical Database Developer

Tarrytown, New York, US
Nov 28, 2018
Required Education
Bachelors Degree
Position Type
Full time
Regeneron Pharmaceuticals, Inc. is seeking a Senior Clinical Database Developer for our Tarrytown, New York location to develop Electronic Data Capture EDC databases for assigned clinical studies using Medidata's Rave platform. Applicant must work collaboratively with Study Data Manager and Clinical Study Team CST to ensure a complete database is developed that supports the study protocol and start-up timelines. The Clinical Database Developer ensures specification updates are made to support protocol data collection and validation requirements for the duration of the study. The Clinical Database Developer ensures completeness and accuracy of eCRF design and adherence to Regeneron data collection standards. Designs unique eCRFs in Rave Architect as defined by the specifications approved by the study team. Interprets study team needs to define and program data validation requirements in Rave Architect . including, but not limited to . edit checks, dynamics, derivations, and custom functions. Perform database testing and release to the study team for User Acceptance Testing UAT , resolving all findings to gain study team approval to release to production. Additionally, the Clinical Database Developer supports the EDC data transfer setup, including Clinical View configuration and testing. Support Study Data Manager with database development and maintenance-related documentation at required intervals. Contribute to and maintain Regeneron standard eCRF Library within Regeneron's implementation of Medidata Rave. Must be able to work independently on multiple concurrent projects with competing timelines, and as part of a project team . Qualified applicants must have, at a minimum, a Bachelor's degree in Electronic Engineering, Computer Science, or a related field, and seven years of experience designing and developing Electronic Data Capture study databases in the pharmaceutical or health-related industry. Qualified applicant must possess seven years of experience with all applicable regulations, including CFR, GCP, and ICH Guidelines. Must have three years of experience with Medidata Rave Architect and Amendment Manager, and have completed the Medidata Study Design and Build Essentials and Amendment Manager training courses or have equivalent training through direct employment experience. Must have three years of hands-on experience using Rave Architect to design and develop Medidata Rave EDC projects including unique form design and programming and validation of edit checks and derivations. Two years of experience supporting clinical studies through post-production changes using Medidata Rave Amendment Manager to perform study migrations and publish checks tasks. Must possess one year of experience with C# programming language, and one year of Custom Function programming experience. Must possess one year of experience integrating Rave EDC with IXRS and/or eCOA systems. To apply for this position, please submit your resume, indicating Requisition Code 14653BR to . Chad Barney Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591 #LI-DNI #GD-DNI #IN-DNI