Clinical Trial Manager – Oncology & Biologics
Company: Genmab
Job ID: R15052
Category: Development Operations
Location: Princeton, New Jersey, USA
Career Level: Mid-Senior
About the Role
Genmab is seeking a Clinical Trial Manager (CTM) to oversee and manage clinical trials from start-up through close-out. The CTM is accountable for trial deliverables, site management, vendor oversight, and risk assessment, ensuring that trials are conducted according to ICH-GCP, Genmab SOPs, and regulatory standards. This role requires collaboration with cross-functional teams and external stakeholders to deliver high-quality clinical data and support patient safety.
Key Responsibilities
Trial Planning and Oversight
Develop operational plans, manuals, and charters for assigned trials.
Review trial protocols, amendments, and Investigator’s Brochures (IB) from a DevOps perspective.
Coordinate Investigational Medicinal Product (IMP) Plans, Trial Oversight Plans, and Regulatory Green Light packages.
Support Global Master Informed Consent Form (ICF) development and CTA/DSUR submissions.
Track and resolve findings from Trial Oversight activities.
Site Selection and Management
Lead site selection in collaboration with start-up teams.
Review and approve SSV summaries.
Coordinate CRO country-specific ICFs, including translation and back-translation processes.
Management and Oversight
Oversee vendor performance and approve key CRO staff.
Conduct Protocol Deviation assessments and track trends.
Ensure completeness of the electronic Trial Master File (eTMF).
Maintain Trial Management Dashboard (TMD) and portfolio applications in GenSense.
Support RBQM and risk management activities.
Facilitate study escalations, audits, and inspection readiness.
Trial Execution
Collaborate with Clinical Management Team (CMT), CROs, and functional representatives.
Track trial-related items such as scans, lab samples, and data transfers.
Monitor trial budgets, forecasting, and invoice management.
Drive timely delivery of trial milestones, maintaining compliance with regulatory standards.
Additional Responsibilities
Lead and mentor cross-functional trial teams.
Proactively identify and mitigate risks to patient safety and data integrity.
Participate in project- and department-level initiatives to optimize processes.
Requirements
Bachelor’s degree in Science or related field.
5–8+ years of clinical trial management experience in biotech/pharma, preferably in oncology trials.
Strong knowledge of ICH-GCP, SOPs, and clinical development processes.
Proven experience in site management, vendor oversight, and risk assessment.
Excellent planning, organizational, and communication skills.
Ability to lead cross-functional teams and coordinate complex trial activities.
Compensation (US-Based Roles)
Salary Range: USD 113,840 – 170,760 annually
Salary offers depend on experience, qualifications, and location. Some 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
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 to improve patient outcomes.
Detail-oriented, precise, and proactive in trial management.
Strong collaborator capable of coordinating across diverse teams.
Innovative problem solver who thrives in fast-paced environments.
Committed to compliance, quality, and high standards of patient safety.
About Genmab
Genmab is a global biotechnology company specializing in innovative antibody therapeutics that transform patient care. For over 25 years, Genmab has pioneered next-generation antibody technology platforms, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators. Headquartered in Copenhagen, Denmark, Genmab has a presence across North America, Europe, and Asia-Pacific.
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