Remote: Senior Manager — Clinical Data Management

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 134.000 - 219.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Clinical Data Management to lead the Data Management team across multiple trials in a hybrid/remote setup in the United States. You will oversee study data management from start-up to lock, ensuring regulatory compliance and high-quality data delivery.

You will manage a team of data managers, collaborate with study teams and CROs, review essential documentation, and drive process improvements to support Regeneron’s mission of

Qualifikationen

• 8+ years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
• Proven record of leading studies and study teams in a data processing environment.
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.

Aufgaben

• Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials.
• Oversee data management activities from study start-up through database lock and archiving.
• Provide sponsor oversight of CRO data management work and drive gaps to resolution.
• Review and approve data management plans, CRF design, and data transfer specifications.
• Maintain inspection readiness and eTMF documentation for quarterly compliance reviews.
• Monitor data quality, deliverable timelines, and risks; address issues proactively.
• Manage, coach, and develop data management staff, including recruitment and performance management.
• Lead process improvements, cross-functional initiatives, and training as a SME.

Kenntnisse

Data management leadership

Regulatory compliance

Project management

Stakeholder communication

People management

Ausbildung

Bachelor’s degree in science

Jobbeschreibung

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Clinical Data Management to lead the Data Management team across multiple trials in a hybrid/remote setup in the United States. You will oversee study data management from start-up to lock, ensuring regulatory compliance and high-quality data delivery.

You will manage a team of data managers, collaborate with study teams and CROs, review essential documentation, and drive process improvements to support Regeneron’s mission of