Temporary-Clinical Data Manager

Temporary-Clinical Data Manager - R50831 Location US

Position Description At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Data Manager to join our Clinical Data Management team, supporting our clinical studies in a Remote work model. In this role, you will ensure clinical data is accurate, compliant, and ready for analysis while collaborating with vendor Project Managers, Clinical Data Managers, CROs, and cross-functional study teams.

Roles Responsibilities

• Serve as the primary data management contact for assigned studies, representing the function on project teams and partnering with CROs
• Coordinate and lead clinical data management activities in line with company SOPs, policies, and regulatory requirements
• Monitor CRO data clean-up from study start-up through data archiving to protect data quality and integrity
• Coordinate medical coding, data validation checks, and database snapshots, and provide data for analysis
• Create and maintain study documentation, including the Data Management Manual, CRF completion guidelines, and validation specifications
• Design and modify CRFs, and initiate and approve the build, testing, and validation of clinical databases
• Prepare and distribute project status reports to project teams and management
• Lead the DM team in ensuring databases are validated and ready for transfer and analysis, while supporting standardization of outsourcing partner processes

Skills

• Bachelor?s degree in mathematics, Science, or a related field
• 3 years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry
• Ability to coordinate and manage CRO data managers and project teams to ensure work follows policies and procedures
• Strong understanding of data management processes, database validation, and regulatory compliance
• Excellent collaboration, organization, and communication skills
• Previous oncology and/or ophthalmology experience preferred

Education

• Bachelor?s degree in mathematics, Science, or a related field