Genmab · 21 hours ago
Senior Clinical Trial Manager
Princeton, NJ
Full-time
Hybrid
Senior Level
$122K/yr - $183K/yrGenmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Senior Clinical Trial Manager (CTM) plays a crucial role in supporting Clinical Trial Teams and ensuring the smooth operation of clinical trials, which includes planning, execution, and compliance oversight.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards. Review of protocol and protocol amendments
Coordinate the development of and manage updates of the Trial Oversight Plan
Review of the Investigator's Brochure from DevOps perspective
Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions
Review of Regulatory Green Light packages
Review the Development Safety Update Report
Develop the Global Master ICF
Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities
Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines
Coordinate the review of country-specific informed consent forms with internal stakeholders
Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands
Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking
Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance
Maintain relevant sections in Clinical Trial Management Systems and Tools
Drive the Operational Data Base review for the trial
Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively
Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager
Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders
Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed
Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout
Qualification
Required
Experience in clinical trial management and oversight
Knowledge of regulatory requirements and Good Clinical Practice (GCP)
Ability to develop and manage operational plans, charters, and manuals
Experience in vendor management and oversight
Strong collaboration skills to work with cross-functional teams, investigators, and vendors
Ability to monitor and manage vendor deliverables
Experience in trial execution and monitoring
Ability to ensure ongoing accuracy and completeness of the eTMF
Experience in risk-based quality management activities
Ability to support inspection readiness activities and conduct site visits
Strong organizational skills to oversee tracking and reconciliation of trial-related items
Preferred
Experience working in a fast-growing, dynamic company
Strong desire to work in a collaborative team environment
Ability to innovate and grapple with the unknown
Benefits
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
Founded in 1999
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
2026-01-08
Company data provided by crunchbase