Senior CDM Manager & Study Lead (Remote)

Regeneron Pharmaceuticals, Inc; Village of Tarrytown (NY); Vor Ort; USD 173.000 - 187.000; Vollzeit

Zusammenfassung

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

You will coordinate DM activities from study start-up to archiving, ensure data quality, support eCRF and database design, and review study documentation including DMP, CRF, and validation specs. Maintain eTMF documentation and contribute to inspection readiness.

Qualifikationen

• Requires a Bachelor’s degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field and 6 years of clinical data management experience.
• Experience applying 21 CFR Part 11, ICH GCP guidelines and CDISC standards to data collection and management.

Aufgaben

• Coordinate DM activities from study start-up to archiving.
• Provide expertise in data management and support eCRF and database design, ensure data quality.
• Review and approve study documentation including DMP, CRF and validation specs.
• Maintain eTMF documentation and perform quality reviews for inspection readiness.
• Represent DM in study-level forums and meetings; may act as SME and provide training.

Kenntnisse

Data management

Regulatory compliance

Cross-functional coordination

Documentation

Communication

Ausbildung

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

Tools

eCRF systems

CDISC standards

Jobbeschreibung

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

You will coordinate DM activities from study start-up to archiving, ensure data quality, support eCRF and database design, and review study documentation including DMP, CRF, and validation specs. Maintain eTMF documentation and contribute to inspection readiness.