Senior Manager, Clinical Data Management
1 month ago
The Senior Manager, Clinical Data Management oversees clinical data management projects in multiple therapeutic areas, ensuring proper planning and execution of data management deliverables that meet Regeneron standards and timelines. This role involves training direct reports on data management skills and regulatory compliance, as well as coordinating with directors to develop SOPs and data management standards.
Key Responsibilities:
- Serves as primary DM contact for assigned therapeutic areas, interacting with clinical counterparts for project planning and issue resolution.
- Supervises direct DM reports for planning and managing DM activities within assigned therapeutic areas, ensuring timely and quality deliverables within budget.
- Reviews and approves project documentation, including Data Management Manual, CRF Completion Guidelines, and validation specifications.
- Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners.
Requirements:
- Bachelor Degree in Mathematics, Science, or a related field.
- At least 8 years of clinical data management experience in biotech, pharmaceutical, or health-related industry.
- Minimum 3 years of direct people management experience.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
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