Senior Database Developer

Location
Tarrytown, New York, US
Posted
Sep 21, 2018
Ref
13825BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Work with 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. 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. Support Study Data Manager with database development and maintenance related documentations at required intervals.

Essential Duties and Responsibilities include, but are not limited to, 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. Design unique CRFs in Rave Architect as needed per study team requirements.

• 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 complex and new custom functions, work with Medidata to oversee 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.

• When applicable, configure additional Medidata applications including but not limited to Coder and TSDV for use on study.

• Ensure go-live 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.

• 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 programming and adherence to company standards.

• Routine interface with cross-functional team members.

• Act as liaison with CROs/vendors as needed, to establish and ensure company standards (for example, data transfer specifications) are implemented and maintained in all studies.

• Assist Manager to: Support/develop and maintain SOPs related to EDC build process.

• Assist Manager to: Participate and lead Clinical Database Development team meetings when needed.

• Assist Manager to: Support Regeneron Secure Data Transfer system by managing access requests; user admin; user accounts and file structure.

• Assist Manager to: Oversee the URL Core Configuration and iMedidata admin., while managing the needs of our CRO partners using the URL Core Configuration.

Education and Experience:

Bachelor Degree in Math, Science or related field with 4 or more years of combined direct and indirect Rave EDC database development experience in the pharmaceutical or health related industry required. Must have completed all required Rave EDC Development trainings by Medidata and with at least 2 years of hands-on developing EDC database for up to late phase clinical studies.

Knowledge and Specialized Skills:

Experience with managing clinical databases throughout the study lifecycle including design, build, and migration and/or publish checks is required. Programming knowledge is preferred, especially C#, and Medidata Rave Certified Study Builder certification is a plus. Must have knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines and experience with Data Management processes is a plus.

Special Equipment/Program:

Experience in integrating EDC with IVR, ePRO, and other remote data capture systems in the industry.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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