Senior Clinical Data Manager

15 hours ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a highly skilled Senior Clinical Data Manager to join our team at Genmab. As a key member of our clinical operations department, you will be responsible for overseeing the planning, start-up, conduct, and closure of clinical trials.

Key Responsibilities
  • You will act as the point of contact for data management activities across multiple trials, ensuring compliance with regulatory and industry standards.
  • You will oversee the performance of DM CROs and provide expert guidance to trial teams on data management best practices.
  • You will lead the development of data review and cleaning plans, as well as data validation strategies to ensure high-quality data.
  • You will review CRFs to ensure alignment with protocols and perform sponsor acceptance testing of eCRFs.
  • You will define and perform data quality checks, taking corrective action to ensure data integrity.
  • You will oversee key DM documentation and ensure inspection readiness, providing recommendations for improvement.
  • You will drive DM oversight of data releases and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP.
  • You will support process improvement and knowledge management through participation in task forces or projects.
Requirements
  • Bachelor's degree in science or related field.
  • 5-8+ years of experience in clinical data management, with significant hands-on end-to-end experience in biotech/pharma industry.
  • Experience within oncology trials is highly preferred.
  • Strong understanding of GCPs, SOPs, regulatory requirements, and good data management practices.
  • Proficient use of data management systems, advanced knowledge of DM processes, tools, methodologies, and documentation.
  • Project management experience.
What We Offer

As a Senior Clinical Data Manager at Genmab, you can expect a competitive salary of $120,000 - $150,000 per year, depending on location and experience. Our offices are designed as open, community-based spaces that foster collaboration and innovation. You will have the opportunity to work in a fast-growing, dynamic company with a strong focus on employee work-life balance.

Genmab offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off. You will also have access to professional development opportunities and a collaborative environment that encourages growth and learning.

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