Director, Integrated Data Review & Quality Assurance

BioSpace; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking a Director, Integrated Data Review to lead strategic development and execution of integrated data review processes across clinical programs. You will partner with Biostatistics and cross-functional teams to implement scalable data review frameworks, standards, and governance, enabling proactive risk-based identification of data issues and inspection-ready data.

You will drive Data Review Plans, monitor KPIs and quality metrics, and promote adoption of IDR practices across

Qualifications

• 12+ years in Clinical Data Management in biotech/pharma.
• 5+ years in people management and mentoring.
• Expert knowledge of regulatory requirements (ICH, 21 CFR 11).

Responsibilities

• Define and lead the Integrated Data Review (IDR) strategy across the portfolio.
• Oversee Data Review Plans and drive risk-based data quality improvements.
• Develop standardized methodologies, templates, and guidance for study teams.
• Governance, KPIs, and quality metrics to ensure consistency and improvement.
• Collaborate with Clinical Data Reporting and QISS to implement standardized outputs.

Skills

CDM principles

Leadership

RBQM

Data Review

Job description

Regeneron is seeking a Director, Integrated Data Review to lead strategic development and execution of integrated data review processes across clinical programs. You will partner with Biostatistics and cross-functional teams to implement scalable data review frameworks, standards, and governance, enabling proactive risk-based identification of data issues and inspection-ready data.

You will drive Data Review Plans, monitor KPIs and quality metrics, and promote adoption of IDR practices across