Clinical Data Management Expert

12 hours ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About Genmab

We are a biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. Our mission is to push the boundaries of what's possible in oncology.

Senior Clinical Data Manager Role Overview

This role offers a unique opportunity for a seasoned clinical data management expert to join our team and contribute to the success of our clinical trials. As a Senior Clinical Data Manager, you will be responsible for overseeing the planning, execution, and closure of clinical trials from start to finish.

Key Responsibilities:

  • Oversight of clinical database design, data collection, validation, review, and timelines.
  • Act as the point of contact for DM activities for multiple trials, providing oversight of data collection and management per regulatory and industry standards.
  • Provide expertise to trial teams on data management best practices.
  • Lead the creation of data review and cleaning plans, ensuring alignment with protocol requirements.
  • Define and perform data quality checks, taking action to ensure data integrity.
  • Ensure inspection readiness by maintaining accurate documentation.
  • Support process improvement initiatives and drive knowledge management within the team.

Requirements:

  • Bachelor's degree in science or related field.
  • A minimum of 7-8 years of experience in clinical data management, preferably in biotech/pharma industry.
  • Hands-on experience in clinical data management practices, including CDISC (SDTM) and data collection requirements in oncology trials.
  • Proven track record of leading data management activities for multiple clinical trials.
  • Excellent project management skills, with ability to prioritize tasks and manage multiple projects simultaneously.

Salary Range:$160,000 - $200,000 per year, depending on location and experience.

About You

  • You possess a passion for clinical data management and a commitment to delivering high-quality results.
  • You have excellent communication and collaboration skills, with ability to work effectively in a fast-paced environment.
  • You are a proactive problem-solver, with a willingness to take ownership of challenges and drive solutions forward.
  • You have a strong understanding of GCPs, SOPs, regulatory requirements, and good data management practices.

Locations

We offer flexible working arrangements, allowing you to balance your work and personal life. Our offices are designed to foster collaboration and innovation, while providing a comfortable and inspiring work environment.



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