Senior Clinical Data Lead — Trials & Data Quality

Regeneron Pharmaceuticals; Montgomery (AL); On-site; USD 120,000 - 160,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Senior Clinical Data Manager to lead data management activities across multiple trials, from start‑up to archiving, ensuring timely, on‑budget delivery with stringent regulatory adherence.

You will serve as the study DM lead and POC for clinical study teams and CROs, providing expert guidance in eCRF design, data quality, transfers, and database lock, while mentoring virtual teams in a matrix environment.

Qualifications

• Working understanding of all applicable regulations, including 21 CFR Part 11, ICH‑GCP Guidelines, and CDISC standards for data collection.
• Proven record of leading clinical studies in a data processing environment and robust knowledge of Data Management processes and industry standard methodologies.
• Strong problem‑solving, project management, and presentation skills.
• Ability to work efficiently with and empower virtual teams in a matrix environment and understanding of cross‑functional activities.
• Proficient with appropriate EDC applications and Microsoft Office applications; software proficiency with CDMS required; experience with JMP and SAS a plus.
• Bachelor’s degree in Mathematics, Science or a related field with a minimum of 5+ years of clinical data management experience in biotech, pharmaceutical or health‑related industry.

Responsibilities

• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands‑on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database/data quality status.
• Own the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Lead data transfers with CROs and third‑party data sources, SAE/AE reconciliation and MedDRA/WHO‑DD coding.
• Support the transfer, locking, and archiving of study databases.
• Lead scheduling and time constraints across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.

Skills

Data management leadership

Regulatory compliance

Project management

Communication/presentation

Cross-functional collaboration

Education

Bachelor’s degree in Mathematics/Science or related field

Tools

CDMS

SAS

JMP

EDC applications

Microsoft Office

Job description

Regeneron Pharmaceuticals seeks a Senior Clinical Data Manager to lead data management activities across multiple trials, from start‑up to archiving, ensuring timely, on‑budget delivery with stringent regulatory adherence.

You will serve as the study DM lead and POC for clinical study teams and CROs, providing expert guidance in eCRF design, data quality, transfers, and database lock, while mentoring virtual teams in a matrix environment.