Clinical Trial Manager

Clinical Trial Manager

Genmab

Utrecht or Copenhagen

Key Responsibilities

• Support the planning, setup, and execution of global clinical trials, ensuring activities are delivered in accordance with 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 to support site feasibility, selection, activation, and ongoing site management.
• Drive in the oversight of service providers, tracking deliverables, timelines, and quality to ensure alignment with study expectations.
• Support risk identification and mitigation activities, contributing to risk-based quality management throughout the trial lifecycle.
• Drive in managing protocol deviations and trial-level issues, ensuring proper documentation, follow-up, and escalation as needed.
• Support trial data review and performance tracking, contributing to reporting and identification of potential issues.
• Work collaboratively within a global, matrixed team environment, building strong relationships with internal teams, vendors, and investigators.

Qualifications

• Bachelor’s degree in life sciences or related field (Master’s degree preferred).
• 5+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
• Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle.
• Experience managing global, multi-center trials and working in a complex, matrixed organization.
• Project management and service provider oversight skills.
• Good communication, collaboration, and interpersonal skills.
• Oncology and/or therapeutic area–specific experience is highly desirable.