Manager Clinical Data Operations

Regeneron Pharmaceuticals • Warren, MI

23h

About The Position

The Manager, Clinical Data Operations will lead the development and delivery of clinical data visualization solutions to support high-quality clinical trial execution across clinical development programs. This role is responsible for leveraging the data from the Scientific Data Lake to create a unified ecosystem of participant-level data visualizations, data quality oversight, external data reconciliation insights, operational and site performance intelligence, audit trail insights, database-lock readiness indicators, and other KPI metrics. The incumbent will be responsible for enabling a data-driven and actionable insights framework aimed to enhance business capabilities, improve operational efficiencies and oversight, and accelerate decision-making. The ideal candidate will work closely with cross-functional teams to ensure that the clinical data visualization solutions meet the business needs, align with the departmental goals, and adhere to regulatory and compliance standards.

Requirements

• Bachelor’s or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field.
• 7+ years of experience in clinical data, data visualization, or related disciplines, with a strong background in creating interactive reporting solutions, KPIs, and metrics to support clinical trial oversight.
• Proficiency in data visualization tools such as Tableau, Power BI, or Spotfire.
• Experience with optimization and maintenance of data pipelines, workflow automation, data quality standards, and strong understanding of data lifecycle management in a regulated environment.
• Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (e.g., GCP, GDPR, HIPAA).
• Experience with data lakes, data pipelines, data integration, automation, and analytics in a clinical research environment.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead the design and development of clinical data visualization solutions that support participant-level tracking, data quality oversight, operational and site performance insights, audit trail insights, database-lock indicators, and other KPI metrics.
• Ensure that the analytical and visualization solutions provide actionable insights to improve clinical data oversight, facilitate efficient data cleaning and review, monitor operational performance, enable improved visibility and decision-making.
• Engage with cross-functional stakeholders to understand the data needs, define requirements, develop specifications, design and deliver solutions that enhance transparency, efficiency, and operational performance.
• Facilitate alignment between technical teams and business partners to ensure requirements are transformed into scalable, long-term data visualization capabilities.
• Manage the lifecycle of analytical and data visualization solutions from proof-of-concept and requirements gathering through testing, deployment, and continuous improvement.
• Source and integrate data from the Scientific Data Lake, ensuring data quality, consistency, and alignment with business requirements.
• Collaborate with the Scientific Data Lake Operations team to optimize data pipelines, metadata management, and ensure seamless access to required datasets.
• Develop and maintain robust clinical data visualization solutions to provide real-time visibility into study progress and performance and fulfill critical study milestones and priorities to accelerate clinical study execution and improve oversight.
• Deliver operational insights to identify risks, bottlenecks, and opportunities to drive process improvements and optimization initiatives.
• Ensure all data insight and visualization workflows comply with GCP, ICH, GDPR, SOPs, and regulatory expectations.
• Drive adherence to data governance principles to safeguard and maintain the security, privacy, and integrity of clinical data.
• Stay updated on emerging technologies and tools in data visualization and analytics to enhance business capabilities.
• Drive the adoption of innovative solutions to improve the efficiency and scalability of clinical data visualization solutions.
• Provide leadership and guidance to junior team members engaged in the development of clinical data visualization solutions.
• Foster a culture of collaboration, innovation, and continuous improvement within the Clinical Data Operations team.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager