Manager, Clinical Data Management - Study Lead (Remote)

Regeneron Pharmaceuticals; Tarrytown (GA); Remote; USD 173,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead to guide DM activities from study start-up through archiving for small to mid-size studies, in a given therapeutic area.

You will support eCRF and database design and ensure data quality, coordinating with CROs and internal teams. The role includes data quality reviews, study documentation, and maintaining eTMF, with a chance to act as SME on DM topics and represent DM in study-level forums.

Qualifications

• Bachelor's degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field and 6 years of clinical data management experience.
• Experience applying regulations (21 CFR Part 11, ICH GCP) to data collection and management.
• Experience coordinating clinical studies and study teams in a regulated environment.
• Ability to evaluate data workflows and propose process improvements.
• Strong written and verbal communication for crossfunctional teams.

Responsibilities

• Lead data management activities from study start-up to archiving.
• Support eCRF and database design; ensure data quality and timely deliverables.
• Review study documentation (DMP, CRF, validation specs) and maintain eTMF.
• Coordinate data transfers with CROs and document data management processes.
• Represent DM in study-level forums; provide SME input and training as needed.
• Identify data quality issues and propose risk mitigations.

Skills

Clinical Data Management

Regulatory compliance

Cross-functional collaboration

GCP 21 CFR Part 11

Education

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

Tools

eCRF systems

CDISC standards

Job description

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead to guide DM activities from study start-up through archiving for small to mid-size studies, in a given therapeutic area.

You will support eCRF and database design and ensure data quality, coordinating with CROs and internal teams. The role includes data quality reviews, study documentation, and maintaining eTMF, with a chance to act as SME on DM topics and represent DM in study-level forums.