Regeneron · 3 hours ago
Associate Dir, Clinical Data Management Study Lead
Warren, NJ
Full-time
Onsite
Director/Executive
$157K/yr - $257K/yr
10+ years expRegeneron is a biotechnology company that provides oversight of clinical data management projects across multiple therapeutic areas. The Associate Director will lead Data Managers, ensure compliance with regulations, and manage relationships with CROs and vendors to ensure high-quality data management results.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Serves as primary DM contact for assigned therapeutic areas to interact 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 for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget
Mentor junior data managers for skills advancement
If required, leads and performs clinical data management tasks for studies
Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP’s and work instructions in compliance with applicable regulations
Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects
Designs and modifies CRF
Supervises DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities
Coordinates with clinical project team for issue resolution
Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization
Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions
Establishes goals, expectations and accountabilities for direct reports
Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures
Responsible for coaching, handling training and leading the direct reports
Qualification
Required
Bachelor's degree in mathematics, Science or a related field
At least 10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry
Previous oncology and/or ophthalmology experience
Previous managerial experience
Directed and comfortable working in teams
Ability to work and operate independently within a tight time line environment
High degree of creativity, latitude and attention to detail
Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines
Strong communication, leadership and business development skills
Proficient with appropriate EDC applications and Microsoft Office applications
Software proficiency with CDMS
Experience with JMP and SAS
Preferred
Previous managerial experience
Experience with JMP and SAS
Benefits
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-02-02
2026-02-02
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