Senior Clinical Trial Associate

Senior Clinical Trial Associate

Genmab

Copenhagen, Denmark

Does this inspire you and feel like a fit?

The Senior Clinical Trial Associate (Sr. CTA) plays a critical role in ensuring high-quality execution of clinical trials through advanced operational support and oversight. The Sr. CTA independently manages Sponsor eTMF activities across trial, country, and site levels, ensuring TMF completeness, quality, and inspection readiness. This includes conducting regular health checks, overseeing milestone tracking, and collaborating closely with the CTT and CRO partners.

In addition to core CTA responsibilities, the Sr. CTA operates with increased autonomy and accountability, serving as a Subject Matter Expert (SME) for assigned systems and processes. The role includes contributing to the development and refinement of Sponsor materials such as SOPs and Work Instructions, supporting audits and inspections, coordinating key Clinical Trial Team activities, and driving process improvements. The Sr. CTA is expected to demonstrate strong stakeholder management, vendor oversight, and the ability to work effectively within a global, matrixed organization while ensuring compliance with ICH-GCP and regulatory requirements.

Requirements

• Bachelor's or Master's degree in relevant technical area
• 3+ years in clinical trial operations
• Experience in coordination and support activities for clinical trial conduct
• Experience maintaining and tracking critical documentation

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!