Job Title: Principal Clinical Data Manager
Company: Novartis Pharmaceuticals Corporation
Location: East Hanover, New Jersey, USA (Hybrid – Onsite Required)
Job Type: Full-Time | Senior Level | Research & Development
Job ID: REQ-10057792
About Novartis:
Novartis is a global leader in pharmaceutical innovation, committed to improving and extending patients’ lives. Our collaborative, purpose-driven culture empowers teams to deliver high-quality clinical research and data management solutions. We focus on leveraging cutting-edge technology and scientific expertise to accelerate drug development and optimize patient outcomes.
Role Overview:
The Principal Clinical Data Manager will lead and oversee all aspects of clinical data management for assigned global programs, ensuring high standards in quality, cost efficiency, and timeline adherence. This role requires expertise in clinical data strategy, trial oversight, and cross-functional collaboration to ensure data integrity and regulatory compliance across clinical trials.
Key Responsibilities:
Provide leadership and strategic direction for data management across assigned trials and programs, ensuring alignment with program-level and therapeutic area (TA) data strategies.
Act as a key ambassador for Clinical Data Management (CDM) within the organization, demonstrating business value and data-driven insights.
Ensure consistency in data management processes, documentation, and data quality plans across programs.
Maintain awareness of study status, resource requirements, and risks across all trials within assigned programs.
Review protocols and amendments, providing proactive feedback to identify and resolve potential database or study issues.
Apply knowledge of CDISC standards and other industry data standards to guide programming and trial execution.
Collaborate with global cross-functional teams, including Clinical Trial Teams (CTT), project management, and safety teams.
Required Experience & Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a closely related discipline.
Minimum of 5 years in drug development, with at least 3+ years in clinical data management.
Strong understanding of clinical trial methodology, GCP guidelines, and medical terminology.
Proven leadership, organizational, and collaboration skills with ability to manage multiple trials simultaneously.
Proficiency in data interrogation, analysis, and use of CDM tools and GUIs.
Strong problem-solving skills with the ability to anticipate risks and implement effective solutions.
Excellent communication skills and proven ability to work in a global, matrixed environment.
Knowledge of project management principles to support program delivery.
Preferred Qualifications:
4+ years’ experience in Oncology, especially in Early Development Oncology.
Previous experience in the pharmaceutical industry.
Compensation & Benefits:
Salary Range: $114,000 – $211,000 per year, depending on experience and skills.
Performance-based incentives and eligibility for annual equity awards.
Comprehensive benefits package including health, life, and disability insurance, 401(k) with company match, and generous paid time off.
Why Join Novartis:
Lead high-impact clinical data management initiatives within a global pharmaceutical leader.
Collaborate with top-tier teams across drug development, analytics, and clinical operations.
Access to career development opportunities, scientific learning, and mentorship programs.
Contribute to a mission-driven organization improving patient lives worldwide.
Equal Opportunity & Accessibility:
Novartis is an Equal Opportunity Employer and provides reasonable accommodations for individuals with disabilities. We do not discriminate based on legally protected characteristics.
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