Clinical Trial Manager

Clinical Trial Manager

Genmab

Utrecht or Copenhagen

The Role

At Genmab, we’re looking for a Clinical Trial Manager to join our dynamic global Trial Strategy and Delivery team of over 75 passionate professionals in Denmark, the US, the Netherlands, and Japan. In this role, you’ll manage critical trial activities such as vendor oversight, site selection, and operational setup (e.g., DM, IRT, and eRT) while being part of a team that thrives on collaboration, innovation, and a “knock-your-socks-off” spirit. From Day One, our comprehensive onboarding program will ensure you’re ready to succeed with the support of 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.

Requirements

• Experience: A Bachelor’s or master’s in medical, biological, or pharmaceutical sciences (or equivalent). With 3-5+ years of experience in clinical trial management from a pharmaceutical company and/or CRO, ideally within oncology or first-in-human trials.
• Expertise: Strong knowledge of trial execution, GCP, and clinical drug development, with experience operating in a global setting.
• Skills: Exceptional communication skills (written and verbal), risk management abilities, and stakeholder management.
• Soft Skills: 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.

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!

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