Senior Manager, Clinical Programming | Remote / Home-Based (US)
Job ID: R14378
Category: Development Operations
Job Type: Full-Time
Locations: United States – Remote or office-based (2 locations available)
About Genmab
Genmab is a global biotechnology leader dedicated to transforming patient outcomes through innovative antibody therapeutics. Over 25 years, Genmab has developed proprietary next-generation platforms, including bispecific T-cell engagers, antibody-drug conjugates, immune checkpoint modulators, and effector function-enhanced antibodies.
Headquartered in Copenhagen, Denmark, Genmab operates internationally across North America, Europe, and Asia-Pacific. By 2030, the company aims to redefine treatment for cancer and other serious diseases with its Knock-Your-Socks-Off (KYSO®) antibody medicines.
Learn more at www.genmab.com.
Role Overview
The Senior Manager, Clinical Programming is responsible for the governance, standardization, and integrity of Study Data Tabulation Model (SDTM) standards across Genmab’s clinical programs. This role oversees programming activities, ensures compliance with CDISC and regulatory standards, and drives consistency and quality across datasets and systems. The Senior Manager will also serve as a subject matter expert (SME) for standards, data management processes, and cross-functional programming initiatives.
Key Responsibilities
Develop, implement, and maintain SDTM standards aligned with scientific, regulatory, and organizational requirements.
Review study eCRFs, support external data collection standards, and provide SDTM mapping guidance.
Ensure compliance of SDTM datasets and study submission packages with CDISC, FDA, ICH, and GCP guidelines.
Act as a subject matter expert on data standards, reporting, and analysis.
Create and maintain quality control processes, metrics, and documentation to ensure adherence to standards.
Define standards specifications in collaboration with implementation teams (database setup, CRF design, algorithm specifications, reporting requirements).
Support continuous process improvement and drive a high level of customer service in standards management.
Collaborate with Digital Solutions and IT to implement technology-enabled processes and tools for clinical trials.
Serve as liaison between Clinical Programming and External Data Management to resolve SDTM-related issues.
Train and mentor team members in SDTM standards, programming processes, and tools.
Required Qualifications
Education: Bachelor’s degree in Statistics, Computer Science, or Life Sciences; Master’s preferred.
Experience: 6–8 years in clinical programming, pharmaceutical, biotech, CRO, or regulatory environments.
Strong SAS programming skills (6–8 years); experience with R preferred.
Demonstrated knowledge of clinical research, metadata management, CDISC standards, FDA/ICH regulations, and GCP.
Experience managing multiple tasks, complex projects, and cross-functional teams in a matrix environment.
Excellent verbal and written communication skills, with the ability to work independently across multiple studies.
Technical expertise in standards management, clinical data management, and trial management preferred.
Compensation and Benefits (US-Based Candidates)
Base Salary Range: USD 122,480 – 183,720 annually, dependent on experience, qualifications, and location.
Eligibility for discretionary bonuses and long-term incentives.
Comprehensive medical, dental, and vision coverage.
401(k) plan with company match.
Paid vacation, sick leave, holidays, and discretionary parental leave.
Access to wellness, financial planning, and lifestyle support programs.
Commuter benefits, tuition reimbursement, and Lifestyle Spending Account for personal wellness.
About You
Passionate about advancing clinical programming and data standards in clinical research.
Precision-driven with strong problem-solving skills and attention to detail.
Collaborative and adaptable team player in a fast-paced, dynamic environment.
Committed to continuous learning, mentoring, and enabling best practices across teams.
Innovative, proactive, and ethically aligned with organizational standards.
Gujarat :
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