Clinical Trial Manager
Genmab
August 31, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Key Responsibilities:
- Support the planning, setup, and execution of global clinical trials, ensuring activities meet timelines, quality standards, and regulatory requirements.
- Ensure trial oversight by maintaining accurate documentation and participating in inspection readiness activities.
- Collaborate with CROs and internal stakeholders for site feasibility, selection, activation, and ongoing site management.
- Oversight of service providers by tracking deliverables, timelines, and quality to align with study expectations.
- Support risk identification and mitigation, contributing to risk-based quality management throughout the trial lifecycle.
- Manage protocol deviations and trial-level issues with proper documentation, follow-up, and escalation as needed.
- Support trial data review and performance tracking to inform reporting and identify potential issues.
- Work collaboratively in a global, matrixed environment, building relationships with internal teams, vendors, and investigators.
Qualifications:
- Bachelor’s degree in life sciences or related field (Master’s preferred).
- 5+ years of clinical trial management experience in pharma/biotech.
- Solid understanding of ICH/GCP and the clinical drug development lifecycle.
- Experience managing global, multi-center trials in a complex, matrixed organization.
- Project management and service provider oversight skills.
- Strong communication, collaboration, and interpersonal skills.
- Oncology and/or therapeutic area experience highly desirable.
- Support the planning, setup, and execution of global clinical trials, ensuring activities meet timelines, quality standards, and regulatory requirements.
- Ensure trial oversight by maintaining accurate documentation and participating in inspection readiness activities.
- Collaborate with CROs and internal stakeholders for site feasibility, selection, activation, and ongoing site management.
- Oversight of service providers by tracking deliverables, timelines, and quality to align with study expectations.
- Support risk identification and mitigation, contributing to risk-based quality management throughout the trial lifecycle.
- Manage protocol deviations and trial-level issues with proper documentation, follow-up, and escalation as needed.
- Support trial data review and performance tracking to inform reporting and identify potential issues.
- Work collaboratively in a global, matrixed environment, building relationships with internal teams, vendors, and investigators.
Qualifications:
- Bachelor’s degree in life sciences or related field (Master’s preferred).
- 5+ years of clinical trial management experience in pharma/biotech.
- Solid understanding of ICH/GCP and the clinical drug development lifecycle.
- Experience managing global, multi-center trials in a complex, matrixed organization.
- Project management and service provider oversight skills.
- Strong communication, collaboration, and interpersonal skills.
- Oncology and/or therapeutic area experience highly desirable.