Regeneron · Hyderabad, IndiaPrepare for this interview
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About Regeneron Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. As a Senior Specialist, EDC Administration , you will support and lead EDC system administration activities across Regeneron's clinical trial portfolio. You will serve as a key operational resource responsible for Medidata Rave administration, user access management, study environment setup, and ongoing platform support while collaborating with CRO partners and cross-functional stakeholders to ensure compliant and efficient clinical data operations. This position is office-based and will be on site at Regeneron's Hyderabad office. A typical day may include the following: Administer Medidata Rave user management activities including user account setup, role assignments, access provisioning, modifications, and deactivations Configure and maintain study environments and handle production participant access within Medidata Cloud Administration Serve as the main point of contact for EDC access-related queries from internal teams and CRO partners Maintain and update user access records, reports, dashboards, and operational metrics across the study portfolio Perform study archiving activities and handle database access workflows across EDC, SharePoint, and other clinical data systems Coordinate EDC administration timelines, breakthroughs, environment setup deadlines, and release readiness activities Provide operational support for inspection readiness activities, audit trails, and compliance documentation related to EDC administration Partner with Clinical Data Management teams and CROs to support database development operational meetings and issue resolution Deliver training and mentorship on EDC administration standards, Medidata platform capabilities, and access management workflows Contribute to process improvements, SOP development, platform upgrades, migrations, and system integration projects This job may be for you if you have: Strong expertise in Medidata Rave administration including Cloud Administration, User Management, environment configuration, and PDF Generator Knowledge of clinical data management processes and EDC platform administration standards Understanding of 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards in regulated clinical environments Solid understanding of access controls, audit trail requirements, and compliance documentation Excellent interpersonal skills with the ability to handle high-volume operational tasks accurately and efficiently Good communication, problem-solving, and stakeholder management skills Ability to work effectively in cross-functional and virtual team environments Experience developing and improving operational workflows and standard processes Strong time management skills with the ability to manage multiple concurrent studies and priorities Proficiency with SharePoint, Microsoft Office Suite, and collaboration tools To be considered for this role , you must have a minimum of 4+ years of experience in the biotechnology, pharmaceutical, or healthcare industry, including at least 2 years of direct EDC administration or clinical systems administration experience. Experience with Medidata Rave platform administration is required. A bachelor's degree in mathematics, science, information systems, or a related field is preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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
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