Senior CDM Study Lead - Data Quality & Delivery

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

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead in Tarrytown, NY to serve as the primary DM supporting clinical study teams and external partners on small or noncomplex studies or larger studies within a therapeutic area.

Coordinate all DM activities from study start-up to archiving. Provide expertise in data management, support eCRF and database design, and ensure data quality.

Qualifications

• Bachelor's degree in math, pharmaceutical science, pharmaceutics, or related field.
• 6 years of clinical data management experience in biotechnology/pharmaceuticals.
• Experience with regulatory guidelines (21 CFR Part 11, ICH GCP) and CDISC standards.
• Ability to coordinate DM activities across study teams and CROs.

Responsibilities

• Lead DM activities from study start-up to archiving.
• Support eCRF and database design; ensure data quality.
• Coordinate data transfers with CROs and monitor data quality issues.
• Review and approve study documentation (DMP, CRF, validation specs).
• Maintain eTMF documentation and inspection readiness.

Skills

Clinical Data Management

Regulatory compliance

Cross-functional collaboration

Data quality assurance

Documentation

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead in Tarrytown, NY to serve as the primary DM supporting clinical study teams and external partners on small or noncomplex studies or larger studies within a therapeutic area.

Coordinate all DM activities from study start-up to archiving. Provide expertise in data management, support eCRF and database design, and ensure data quality.