Senior Manager, Clinical Programming
Company: Genmab
Job ID: R14378
Category: Development Operations
Locations: Multiple locations (Global)
Work Model: Hybrid / Onsite (location-dependent)
Career Level: Senior Manager
Job Overview
Genmab, a global biotechnology company, is seeking a Senior Manager, Clinical Programming to lead the development and governance of Study Data Tabulation Model (SDTM) standards. This role ensures data quality, consistency, and compliance across clinical trials to support regulatory submissions and high-quality analysis across Genmab’s oncology and antibody therapeutic programs.
The Senior Manager will provide sponsor oversight of programming activities with vendors, collaborate closely with Clinical Operations, Data Management, and Digital Solutions teams, and implement standards and tools that drive operational excellence and data integrity.
Key Responsibilities
Develop and implement company-wide SDTM standards aligned with CDISC and other industry guidelines
Review study eCRFs and support the creation of external data collection standards, providing SDTM mapping guidance
Serve as a subject matter expert on CDISC, data standards, regulatory requirements, and programming processes
Ensure SDTM datasets are compliant with regulatory submission requirements and maintain data integrity
Support knowledge development within the team on standards, reporting, analysis, change control, and tools
Establish quality control processes, metrics, and measures to ensure compliance with standards
Define standards specifications in collaboration with implementation teams, including database setup, CRF design, algorithms, and reporting
Facilitate continuous process improvement and ensure high-quality customer service
Partner with Digital Solutions and IT to implement strategies, tools, and technology-enabled processes for clinical trial standards and data management
Act as liaison between Clinical Programming and External Data Management to resolve data standardization issues proactively
Required Qualifications & Experience
Bachelor’s degree in Statistics, Computer Science, Life Sciences; Master’s degree preferred
6–8 years of relevant experience in pharmaceutical, biotech, CRO, or regulatory settings
Strong proficiency in SAS programming (6–8 years experience); experience with R preferred
Knowledge of clinical research, metadata management, CDISC standards, FDA & ICH guidelines, GCP
Experience managing complex projects and cross-functional teams to meet timelines and deliverables
Strong communication and presentation skills, able to work independently in a multi-study, matrixed environment
Experience with clinical data management and trial management preferred
Compensation (United States)
Salary Range: USD 122,480 – 183,720 annually
Actual salary will depend on candidate qualifications, experience, and location. Additional incentives may include performance-based bonuses and long-term compensation programs.
Employee Benefits (US-Based Roles)
401(k) plan with company match
Comprehensive medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and paid parental leave
Wellness and lifestyle spending benefits
Tuition reimbursement and commuter benefits
Family care, financial wellness, and emotional well-being support programs
About Genmab
Genmab is a global biotechnology company dedicated to improving patient outcomes through innovative antibody therapeutics. For over 25 years, Genmab has combined next-generation antibody technology, translational science, and data-driven innovation to deliver life-changing therapies. Headquartered in Copenhagen, Denmark, Genmab operates across North America, Europe, and Asia-Pacific, focusing on oncology and other serious diseases.
Why Join Genmab
Lead clinical programming and SDTM standardization for global trials
Shape high-quality, compliant, and innovative clinical data strategies
Collaborate with a multidisciplinary, global team of experts
Make a meaningful impact on patient safety, data quality, and regulatory compliance
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