Specialist, EDC UAT, QC & Development

Summary:

The Specialist, EDC UAT, QC & Development, under limited supervision, performs EDC database development, User Acceptance Testing (UAT), and Quality Control (QC) activities for assigned clinical studies. Works collaboratively with CRO Clinical Database Developers and Clinical Data Management to ensure Database Development functions are performed in compliance with Regeneron procedures, clinical data standards, SOPs, policies, and best practices. Serves as a key contributor in ensuring the quality and integrity of EDC systems from build through go-live.

Job Duties:

EDC User Acceptance Testing (UAT)

• Perform the UAT process end-to-end for assigned studies: Contribute to UAT Plan, Create UAT site and publish EDC system in UAT environment; develop and/or review UAT test scripts to ensure comprehensive coverage of eCRF design, edit checks, dynamics, derivations, and custom functions.
• Invite Regeneron and CRO UAT participants via Cloud Administration. Coordinate and facilitate UAT execution, ensuring all test scenarios are completed and documented.
• Track, triage, and resolve reported issues for the duration of UAT until the system is deemed ready for go-live. Provide UAT summary documentation and sign-off recommendation.

Database Validation

• Perform Quality Control (QC) and review of EDC database builds (internal and CRO-developed) to verify accuracy and compliance with protocol requirements, annotated CRFs, and Regeneron standards: QC of eCRF design, form layouts, field properties, and data dictionaries; QC of edit checks, derivations, dynamics, and custom function logic and firing patterns; QC of external system integrations and data load configurations.
• Document QC findings, track defect resolution, and verify corrections prior to UAT or go-live.
• Contribute to the development and continuous improvement of QC checklists, QC procedures, and UAT templates/tools.

EDC Development

• Perform Clinical Database Development activities for assigned studies: Create study on Medidata URL; Rave User Administration including AE/SAE alert and IRT account setup; Project registration in Rave Coder; AE/SAE alert custom function code review; eLearning mapping; assigning Rave Admin team access; requesting FTP folder mapping; Clinical view setup and rebuilds/refreshes.
• Build early to late phase studies in Medidata Rave based on portfolio needs. Work with Clinical Study Team through Study Data Manager to implement a comprehensive eCRF system in Rave Architect using the Global CRF Library and new unique CRFs per protocol requirements.
• Program data validations in Rave Architect, including edit checks, dynamics, derivations, and custom functions prior to completion of eCRF build.
• When applicable, work with 3rd party vendors on EDC system integration and perform external data loads (e.g., IxRS, labs, etc.).
• When applicable, configure additional Medidata applications including but not limited to Coder and TSDV.
• Manage post-production change activities using Rave Amendment Manager to perform Migrations or Quick Publish changes.

General Responsibilities

• Contribute to Database Development operational meetings with DM CRO partners.
• Track milestones/deliverables, escalate and follow to resolution as necessary.

Job Requirements:

• Medidata Rave experience is required.

• Medidata Builder Certification is a plus.
• C# programming knowledge is a plus.
• TrialGrid knowledge is a plus.
• Demonstrates working understanding of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
• Demonstrates robust knowledge of Data Management and Database Development processes and industry best practices.
• Demonstrates strong understanding of UAT methodologies, test script development, and defect management in clinical EDC systems.
• Demonstrates attention to detail and a quality-focused mindset with proven ability to identify, document, and resolve data system defects.
• Ability to work effectively with virtual teams in a matrix environment.
• Strong understanding of cross-functional activities.
• Effective time management to meet objectives.
• Ability to adjust in a fast-paced environment.

Experience:

Minimum of 3+ years of EDC development experience in biotechnology, pharmaceutical, or health-related industry is required. Demonstrated experience in UAT coordination/execution and QC of EDC systems is strongly preferred.

Education: Bachelor's degree in mathematics, science, or related field.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.