Regeneron Pharmaceuticals Clinical Operations Manager

Clinical Data Management Strategy

The Clinical Data Management Strategist leads the development and implementation of data management strategies for programs in Clinical Data Management. This role ensures compliance with ICH/GCP regulations and company SOPs while overseeing data management activities, decisions, and timelines within assigned programs.

Key Responsibilities:

• Develops and implements data management strategies to ensure quality, timelines, and resource allocation;
• Collaborates with cross-functional teams to provide CDM expertise during protocol design, study start-up, and conduct phases;
• Ensures consistency across programs and develops standardized methodologies within CDM;
• Manages program-level result timelines, allocating resources and supervising overlapping deliverables;
• Liaises with stakeholders to oversee study budgets, review initial budgets, and manage changes throughout the program lifecycle;

Requirements:

• Bachelor's degree in Mathematics, Science, or a related field;
• Minimum 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industries required;
• 5 years of people management experience preferred;