Remote CDM & Study Lead — Data Quality & Delivery

Regeneron Pharmaceuticals; Village of Tarrytown (NY); On-site; USD 173,000 - 187,000; Full time

Benefits offered by this job

Bonuses

Equity awards

Retirement benefits

401(k)

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, located in Tarrytown, NY, seeks a Manager in Clinical Data Management (CDM), Study Lead to support study teams and external partners on small or larger studies within a therapeutic area.

You will coordinate DM activities from start-up to archiving, provide data management expertise, support eCRF and database design, and ensure data quality and inspection readiness. Potential SME responsibilities and crossfunctional collaboration are expected.

Qualifications

• Bachelor's degree and 6 years of clinical data management experience in biotech/pharma.
• Experience applying 21 CFR Part 11, ICH GCP, and CDISC standards to data collection/management.
• Experience coordinating clinical studies and study teams in regulated environments.
• Experience applying DM processes and industry best practices across the data lifecycle.
• Experience evaluating DM workflows and recommending improvements.
• Experience resolving complex data issues by analyzing requirements and root causes.
• Experience delivering written documentation and crossfunctional communications.

Responsibilities

• Coordinate all DM activities from study start-up to archiving.
• Provide expertise in data management, support eCRF and database design, ensure data quality.
• Perform data quality reviews, data acceptance, and coordinate data transfers with CROs.
• Document and support CRO DM activities, ensuring SOP adherence and issue identification.
• Review and approve study documentation including DMP, CRF, and validation specs.
• Maintain eTMF documentation and perform quality reviews for inspection readiness.
• Ensure DM deliverables align with timelines and business needs.
• Monitor data quality and propose mitigations; act as SME when needed.

Skills

Data management

CRO coordination

Regulatory compliance

Documentation

Crossfunctional collaboration

Problem solving

Education

Bachelor's degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field

Tools

eCRF systems

Database design tools

Job description

Regeneron Pharmaceuticals, located in Tarrytown, NY, seeks a Manager in Clinical Data Management (CDM), Study Lead to support study teams and external partners on small or larger studies within a therapeutic area.

You will coordinate DM activities from start-up to archiving, provide data management expertise, support eCRF and database design, and ensure data quality and inspection readiness. Potential SME responsibilities and crossfunctional collaboration are expected.