Senior Clinical Data Manager | Princeton, New Jersey, USA
Job ID: R14727
Category: Development Operations
Job Type: Full-Time
About Genmab
Genmab is a global biotechnology leader focused on developing innovative antibody therapeutics that transform patient care in oncology and other serious diseases. With a strong 25-year track record, Genmab’s proprietary pipeline includes bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators.
Headquartered in Copenhagen, Denmark, Genmab operates internationally across North America, Europe, and Asia-Pacific, fostering a culture of scientific excellence, innovation, and collaboration.
Learn more at www.genmab.com.
Role Overview
The Senior Clinical Data Manager plays a pivotal role in planning, start-up, conduct, and closure of clinical trials, ensuring high-quality data management in alignment with ICH-GCP, SOPs, and regulatory requirements.
This role may encompass two key responsibilities:
Data Manager: Operational responsibility for individual trials, including EDC setup, data validation, vendor oversight, and trial deliverables.
Lead Data Manager: Oversight of multiple trials across development projects, ensuring consistency, process improvement, and high standards of data management.
Senior Data Managers also provide mentorship, training, and strategic guidance within the Clinical Data Management (CDM) function.
Key Responsibilities
Trial Management & Oversight
Deliver core trial deliverables: EDC setup, data collection, validation, and database closure.
Ensure effective CRO/vendor oversight and adherence to project timelines.
Provide input on protocols, randomization/stratification plans, tables, figures, and listings.
Support risk management, blinding procedures, and compliance.
Attend trial meetings, investigator meetings, and operational committees.
Data Strategy & Vendor Collaboration
Define and review scope of work, work orders, and change orders for data management, ePRO, and IRT systems.
Participate in vendor qualification, RFPs, and operational alignment meetings.
Drive process improvements and lessons learned across projects.
Compliance & Quality
Ensure adherence to GCP, SOPs, regulatory standards, and Genmab’s Code of Business Ethics.
Support audits and inspections, including root cause analysis and corrective action implementation.
Maintain oversight of trial eTMF, data packages, and dashboards.
Leadership & Mentorship
Train and guide colleagues on data management processes and best practices.
Lead and contribute to cross-departmental initiatives and task forces.
Promote knowledge sharing and process standardization within CDM.
Required Qualifications
Bachelor’s degree in Science or related field.
5–8+ years of experience in clinical data management within biotech or pharma, with hands-on end-to-end trial management.
Experience in oncology trials highly preferred.
Strong knowledge of CDM systems, data validation, EDC, IRT, and ePRO processes.
In-depth understanding of GCP, SOPs, and regulatory guidelines (FDA, EMA, ICH).
Proven experience in project management and leadership of cross-functional trial teams.
Competencies
Strategic planning and organization
Clinical trial conduct and ICH-GCP compliance
Team leadership and mentorship
Analytical and problem-solving abilities
Strong communication and scientific writing skills
Quality mindset with attention to detail
IT proficiency with data management systems
Compensation & Benefits (U.S.)
Salary Range: $124,320 – $186,480 annually (depending on experience, skills, and location)
Benefits Include:
401(k) Plan: 100% match on the first 6% of contributions
Health Coverage: Medical, dental, vision, and HSA options
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary parental leave
Wellness & Lifestyle: Access to backup care, financial wellness tools, tuition reimbursement, and Lifestyle Spending Account
Additional Perks: Commuter benefits, voluntary insurance plans, and discretionary bonuses
About You
Passionate about clinical data management and operational excellence
Collaborative, innovative, and proactive in cross-functional projects
Dedicated to delivering high-quality trial data and regulatory compliance
Able to mentor, guide, and enable teams for optimal performance
Comfortable working in a fast-paced, dynamic biotech environment
Gujarat :
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