Remote CDM Study Lead & Data Quality Manager

Regeneron Pharmaceuticals, Inc; Oregon; Hybrid; USD 115.000 - 187.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Manager CDM to oversee lead Data Manager(s) on clinical data management studies, ensuring proper planning and timely delivery of data deliverables that meet Regeneron standards.

The role supports SOPs and data management plans, with remote work and up to 25% travel. The candidate will lead studies, liaise with CROs, design eCRF and databases, and monitor data quality and reporting throughout the study lifecycle.

Qualifikationen

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
• Perform quality review and inspect readiness tasks to meet quarterly Inspection Readiness
• Lead/oversee all data management deliverables for assigned studies; ensure timelines and plans are developed and reviewed with CST

Aufgaben

• Serve as the DM study lead and primary contact for clinical study teams and external partners
• Provide expertise in data management to support clinical studies
• Oversee procedures for data quality review and data acceptance prior to analyses or database lock
• Manage data transfers with CROs and third‑party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding
• Support transfer, locking, and archiving of study databases and scheduling across projects
• Prepare recommendations for new or improved data management processes and data flow
• Escalate and follow to resolution as necessary

Kenntnisse

Data management

Leadership

Communication

Ausbildung

Bachelor Degree or equivalent in Mathematics, Science or related field

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a Manager CDM to oversee lead Data Manager(s) on clinical data management studies, ensuring proper planning and timely delivery of data deliverables that meet Regeneron standards.

The role supports SOPs and data management plans, with remote work and up to 25% travel. The candidate will lead studies, liaise with CROs, design eCRF and databases, and monitor data quality and reporting throughout the study lifecycle.