Specialist, EDC Administration

Summary:

The Specialist, EDC Administration, under limited supervision, leads and performs EDC system administration activities across the Regeneron clinical trial portfolio. Serves as a key operational resource responsible for Medidata Rave environment setup, user access management, and platform administration. Works collaboratively with CRO partners, Clinical Data Management, and cross-functional stakeholders to ensure EDC administrative functions are performed accurately, and in compliance with Regeneron procedures, SOPs, and regulatory requirements.

Job Duties:

User Access Management & Administration

• Administer Rave User Management activities for assigned studies: Set up and maintain user accounts, roles, and permissions in Medidata Cloud Administration; manage production participant access; process access requests, modifications, and deactivations based on established workflows.
• Maintain and update records/reports of user access across EDC systems.
• Serve as a point of contact for EDC access-related queries from internal teams and CRO partners. Escalate issues to supervisors or senior team members as appropriate.

Operational Support & Process Management

• Perform archiving activities for assigned studies
• Directly administer the database access interface based on request form workflows (EDC, SharePoint, other data systems)
• File data management documents from legacy studies into the Trial Master File
• Maintain and update records/reports of users’ access
• Attend events and record project team output as assigned
• Coordinate and manage the EDC Administration calendar, tracking key milestones across studies (environment setup deadlines, access provisioning timelines, go-live readiness checkpoints).

Cross-Functional Collaboration & Training

• Contribute to Database Development operational meetings with DM CRO partners, representing EDC administration topics.
• Contribute to special projects requiring EDC administration input, including platform upgrades, migrations, and system integrations.
• Support inspection readiness activities related to EDC system administration, user access audit trails, and platform compliance documentation.

Job Requirements:

·        Medidata Rave experience is required, with knowledge of Rave administration functions (Cloud Administration, User Management, environment configuration, PDF Generator).

·        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 processes and EDC platform administration best practices.

·        Demonstrates strong understanding of access control principles, audit trail requirements, and system compliance in a regulated clinical environment.

·        Ability to work effectively with virtual teams in a matrix environment.

·        Strong understanding of cross-functional activities and stakeholder coordination.

·        Strong ability to manage multiple and varied tasks with enthusiasm; prioritize workload with attention to detail.

·        Effective time management to meet objectives across multiple concurrent studies.

·        Excellent interpersonal, oral, and written communication skills.

·        Proficiency with SharePoint, Microsoft Office Suite, and collaboration tools.

·        Ability to adjust in a fast-paced environment.

Experience:  

Minimum of 3+ years of experience in biotechnology, pharmaceutical, or health-related industry with a minimum of 2 years of direct EDC administration or clinical systems administration experience. Experience with Medidata Rave platform administration is required. Prior experience in user access management and study environment configuration is strongly preferred.

Education:   Bachelor's degree in mathematics, science, information systems, 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.