Senior Clinical Data Manager – Clinical Data Management
Company: Genmab
Job ID: R14727
Category: Development Operations
Location: Princeton, New Jersey, USA
Career Level: Senior Manager / Lead
About the Role
Genmab is looking for a Senior Clinical Data Manager to lead and oversee clinical data management (CDM) activities across multiple trials. This role ensures accurate, high-quality, and compliant data management throughout the clinical trial lifecycle.
The Senior Data Manager may also act as a Lead Data Manager, overseeing multiple trials, mentoring team members, and implementing process improvements. This position represents a key interface with cross-functional teams, vendors, and partners to maintain operational excellence.
Key Responsibilities
Operational & Trial Management
Plan, start-up, conduct, and close clinical trials, ensuring timelines, quality, and budget compliance.
Lead or support cross-functional Clinical Trial Teams (CTT) with EDC setup, data collection, validation, and database readiness.
Provide input on protocol development, amendments, and operational strategies.
Ensure blinding, randomization, and stratification procedures are correctly applied.
Oversee timely delivery of data management deliverables in compliance with ICH-GCP, FDA/EMA guidelines, and Genmab SOPs.
Vendor & CRO Oversight
Manage DM CROs and external vendors, ensuring quality and adherence to deliverables.
Support vendor qualification, scope of work definition, and review/change management (WOs, COs, CNFs).
Participate in operational committees and cross-functional forums representing CDM expertise.
Compliance & Quality Assurance
Maintain compliance with regulations, SOPs, and Genmab Code of Business Ethics.
Support audits and inspections; conduct root cause analysis and implement corrective actions.
Monitor key metrics, data quality dashboards, and trial progress to proactively manage risks.
Department & Project Contributions
Mentor colleagues and provide CDM training.
Lead knowledge-sharing initiatives, SOP revisions, and cross-functional projects.
Follow scientific and technical developments in data management to implement innovative practices.
Requirements
Bachelor’s degree in Science or related field. Advanced degrees preferred.
5–8+ years of hands-on experience in clinical data management in biotech or pharma; oncology trial experience preferred.
Proven expertise in end-to-end CDM processes, including EDC, data validation, coding, and database lock.
Experience managing multiple trials and working with CROs/vendors.
Strong knowledge of GCP, regulatory requirements, SOPs, and project management.
Proficiency in data management systems, dashboards, and IT tools.
Strong analytical, communication, and problem-solving skills.
Compensation (US-Based Roles)
Salary Range: USD 124,320 – 186,480 annually
Salary offers depend on experience, qualifications, and location. Certain roles may include discretionary bonuses or long-term incentives.
Employee Benefits
401(k) plan with 100% match on first 6% contributions
Comprehensive medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and 12 weeks discretionary parental leave
Wellness programs, tuition reimbursement, Lifestyle Spending Account
Family support programs, financial wellness tools, and emotional well-being resources
Commuter benefits
About You
Passionate about Genmab’s mission and improving patient outcomes.
Brings precision, excellence, and innovation to clinical data management.
Collaborative, proactive, and able to mentor and support team members.
Thrives in fast-paced, dynamic environments while maintaining compliance and quality.
Proactive problem-solver with the ability to implement process improvements.
About Genmab
Genmab is a global biotechnology company dedicated to developing innovative antibody therapeutics that improve patient outcomes. With over 25 years of pioneering research, Genmab’s proprietary platforms include bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators. Headquartered in Copenhagen, Denmark, Genmab operates across North America, Europe, and Asia-Pacific.
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