Temporary-Clinical Data Manager

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 85,000 - 110,000; Part time

Job summary

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Temporary Clinical Data Manager to join our Clinical Data Management team, supporting our clinical studies in a remote work model.

You will ensure clinical data is accurate, compliant, and ready for analysis while collaborating with CROs and cross-functional study teams. The role emphasizes data validation, database build and documentation, with opportunities to lead the data management team and contribute to life-changing

Qualifications

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

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

Clinical data management

CRO coordination

Regulatory compliance

Data validation

Team leadership

Oncology experience

Education

Bachelor’s degree in mathematics, science, or related field

Job description

Temporary-Clinical Data Manager - R50831

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Temp-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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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