(Senior) Clinical Trial Manager

Role Summary

Genmab is seeking a (Senior) Clinical Trial Manager to join its global Trial Strategy and Delivery team. You will manage critical trial activities including vendor oversight, site selection, and operational setup (DM, IRT, and eRT) and collaborate with cross-functional teams across Denmark, the US, the Netherlands, and Japan to advance oncology and first-in-human trials. From Day One, you’ll benefit from a comprehensive onboarding program designed to support your success with mentors, colleagues, and stakeholders.

Responsibilities

• Developing operational plans, charters, and trial manuals.
• Reviewing trial protocols, amendments, and other critical trial documents.
• Leading the creation of the Trial Oversight Plan and Global Master ICF, including amendments.
• Coordinating site selection with the Start-Up team, reviewing regulatory documents, and approving site activations.
• Overseeing vendor management, including vendor deliverables, and ensuring alignment on trial activities.
• Supporting trial execution by managing protocol deviations, tracking KPIs/KQIs, resolving site issues, and participating in Risk-Based Quality Management (RBQM) activities.
• Collaborating with cross-functional teams to address escalations and ensure timely issue resolution.
• Participating in inspection readiness, audits, and site monitoring oversight activities as needed.

Qualifications

• Bachelor's or master's degree in medical, biological, or pharmaceutical sciences (or equivalent), with 5-7+ years of experience in clinical trial management from a pharmaceutical company and/or CRO, ideally within oncology or first-in-human trials.
• Strong knowledge of trial execution, GCP, and clinical drug development, with experience operating in a global setting.
• Exceptional communication skills (written and verbal), risk management abilities, and stakeholder management.
• A proactive problem solver who identifies risks and develops effective mitigations. A collaborative leader with a quality mindset, adaptability in fast-paced environments, and the ability to inspire trust.

Skills

• Clinical trial management
• GCP and regulatory compliance
• Global trial operations
• Vendor and site management
• Risk management and issue resolution