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Senior Clinical Data Manager

1 month 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 team, you will be responsible for ensuring the high-quality management of clinical data across multiple trials.

Key Responsibilities
  • Lead the development of clinical database designs and ensure data collection and management meet regulatory and industry standards.
  • Provide oversight of data validation plans and ensure data quality meets expectations.
  • Collaborate with cross-functional teams to ensure timely delivery of data deliverables and support regulatory filings and inspections.
  • Develop and implement data quality checks and ensure data quality meets expectations.
  • Support process improvement and knowledge management initiatives within the department.
Requirements
  • Bachelor's degree in science or related field.
  • 5-8+ years of experience in clinical data management, with significant hands-on experience in end-to-end clinical data management practices.
  • Experience in oncology trials highly preferred.
  • Strong understanding of GCPs, SOPs, regulatory requirements, and good data management practices.
  • Experience with CDISC (SDTM) and data collection requirements in oncology trials preferred.
  • Project management experience.
About You
  • You are passionate about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do and are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
What We Offer

Genmab offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to supporting our employees in achieving their career goals and providing a work-life balance that allows for personal and professional fulfillment.