Provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas
Interacts with clinical counterparts for overall project planning and issue resolution
Projects, allocates and prioritizes DM resources within the assigned therapeutic projects
Supervises direct DM reports and manages all relevant DM activities
Mentors junior data managers for skills advancement
Reviews and approves for final archival of project documentation
Designs and modifies CRF
Contributes to development of Regeneron DM outsourcing strategies
Ensures adequate management of CROs and vendors in the therapeutic projects
Establishes goals, expectations and accountabilities for direct reports
Responsible for coaching, handling training and leading the direct reports

Bachelor’s degree in mathematics, Science or a related field
at least 8-10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry
Previous oncology and/or ophthalmology experience a plus
Previous managerial experience is preferred
directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment
High degree of creativity, latitude and attention to detail required
Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines
Strong communication, leadership and business development skills required
Proficient with appropriate EDC applications and Microsoft Office applications
Software proficiency with CDMS required
Experience with JMP and SAS a plus.

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
paid leaves (e.g., military and parental leave) for eligible employees at all levels

Senior Manager, Clinical Data Management – Study Lead

Key skills