Manager, Clinical Database Development

Manager, Clinical Database Development

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Database Development in Tarrytown, NY to oversee the development and/or technical activities for EDC databases built by CRO partners for assigned studies. Ensure all database build activities are performed according to Regeneron Processes (or CRO processes where applicable). Contribute to the creation of CDASH compliant eCRFs. Maintain and contribute to company standard Global Library. Perform Clinical Database Development activities for all assigned studies. Build early to late phase studies in Medidata Rave independently based on portfolio needs. Provide advanced expertise on Rave database builds to CROs and internal REGN teams. Under direction, support inspection activities related to RAVE and Clinical Database Development. Support the implementation of Database Development strategies for REGN acquisitions. Lead or contribute to special projects that require EDC input. Contribute to Database Development operational meetings with DM CRO partners. Train DM CRO partners on Database Development best practices and REGN requirements. Fulfill the SME role for 1 or more topics. Develop and deliver training. Provide ongoing support for Data management and key stakeholders (as applicable). Track milestones/deliverables, escalate and follow resolution as necessary, and communicate portfolio level updates to internal and CRO developers. Assist in the development of SOPs, Work Instructions, Guidance Manuals, and other Database Development tools. Recommend areas for improvement in Database Development process and practice. Mentor junior staff members.

Telecommuting permitted. 20% domestic travel for client meetings, training, conferences, or other business-related activities.

Job Requirements

Requires a Bachelors degree in Information Technology or related field and 3 years of direct and indirect Rave EDC database development experience. Must have experience with: Medidata Rave; C# programming; SAS programming; Programming in Electronic Data Capture (EDC), Good Clinical Practice (GCP), and Medidata Rave; Programming languages like SAS, PL/SQL, C# and Microsoft office suite (Word, Excel, and PowerPoint); Providing guidance on Rave database builds to CROs and internal teams; 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections; Data Management and Database; Rave URL and database related upgrades; and Creating SAS programs for data extraction and compliance checks. Must have a Medidata Study Builder Certification. 20% domestic travel for client meetings, training, conferences, or other business-related activities.

About the Role and Company

This role is crucial for ensuring the quality and efficiency of clinical trial data management. You will be a key player in developing and maintaining Electronic Data Capture (EDC) databases using Medidata Rave, working closely with CRO partners and internal teams. Your expertise will contribute to compliance with industry standards like CDASH and GCP, and you will have opportunities to lead projects, train others, and mentor junior staff. Regeneron offers a comprehensive benefits package and a collaborative culture.

Key skills/competency

• Clinical Database Development
• Medidata Rave
• EDC Databases
• SAS Programming
• C# Programming
• CDISC Standards
• GCP Compliance
• Data Management
• eCRFs
• Mentoring