Director, Integrated Data Quality & Review

Regeneron Pharmaceuticals; New Jersey; Presencial; USD 183 000 - 305 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals is seeking a Director of Integrated Data Review to provide strategic leadership for data review processes across clinical programs. You will establish scalable frameworks, governance, and metrics enabling proactive identification of data issues and high-quality, inspection-ready data.

The role requires extensive clinical data management experience and leadership in a matrix organization.

Qualificações

• 12+ years in Clinical Data Management within biotechnology, pharmaceutical or health industry.
• 5+ years of people management, leadership and mentoring.
• Expert knowledge of clinical data management principles and industry standards.

Responsabilidades

• Define and lead the Integrated Data Review (IDR) strategy and governance across the portfolio.
• Oversee Data Review Plans execution and identify data quality risks.
• Develop standardized data review templates, processes and guidance for consistency.
• Provide governance over data review outputs, dashboards, and patient profiles.
• Collaborate with QISS to translate risk-based data management into IDR practices.
• Identify potential risks to data quality and timelines and implement mitigation strategies.
• Drive continuous improvement in IDR methodologies and technologies.
• Lead training and change management to ensure adoption of IDR processes.
• Partner with cross-functional teams to support risk-based and integrated data review.

Conhecimentos

Clinical Data Management

Leadership

Regulatory knowledge

RBDM

RBQM

Data governance

Cross-functional collaboration

Strategic thinking

Issue risk management

Descrição da oferta de emprego

Regeneron Pharmaceuticals is seeking a Director of Integrated Data Review to provide strategic leadership for data review processes across clinical programs. You will establish scalable frameworks, governance, and metrics enabling proactive identification of data issues and high-quality, inspection-ready data.

The role requires extensive clinical data management experience and leadership in a matrix organization.