Mgr Clinical Database Development

Role Summary

Location: Tarrytown, NY. The Manager, Clinical Database Development oversees the development and technical activities for EDC databases built by CRO partners for assigned studies. Ensures all database build activities are performed according to Regeneron processes (or CRO processes where applicable) and contributes to CDASH-compliant eCRFs and the Global Library. Performs and leads Clinical Database Development activities across early to late phase studies, with hands-on Medidata Rave expertise and mentorship for internal REGN and DM CRO teams.

Responsibilities

• Oversee and 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 Regeneron 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 one or more topics; develop and deliver training
• Provide ongoing support for Data Management and key stakeholders
• Track milestones and 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 the database development process and practice; mentor junior staff

Qualifications

• Bachelor’s degree in Information Technology or related field
• 3 years of direct and indirect Rave EDC database development experience
• Experience with Medidata Rave; C# programming; SAS programming; EDC, GCP, and Medidata Rave
• Programming languages: SAS, PL/SQL, C#; proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Providing guidance on Rave database builds to CROs and internal teams
• Knowledge of 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections
• Data Management and Database concepts; Rave URL and database upgrades
• Creating SAS programs for data extraction and compliance checks
• Medidata Study Builder Certification

Skills

• Medidata Rave
• C# programming
• SAS programming
• Electronic Data Capture (EDC); Good Clinical Practice (GCP); CDISC standards
• Data Management concepts

Education

• Bachelor’s degree in Information Technology or related field

Additional Requirements

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