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Clinical Trial Manager

Clinical Trial Manager

Genmab

Copenhagen, Denmark

The Role

As Clinical Trial Manager (CTM) at Genmab, you will lead one or more trials ensuring that key project deliverables are met with the overall goal of developing new and innovative treatments for cancer.

The CTM leads the cross-functional trial-specific trial team, including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs and ICH-GCP.

Trial Management currently employs 16 people of which 13 are located in Denmark and the new CTM reports to Director, Team Lead, Trial Management

Responsibilities

  • You will act as lead for the trial team and be overall responsible for trial related activities from start up to reporting of a clinical trial in close collaboration with CROs
  • You will be responsible for securing trial deliverables in a proactive and motivational fashion, through transparent communication and great teamwork throughout all stages of trial conduct
  • You will ensure proper documentation, record management, risk assessment/management, trial budgets as well as ensuring sponsor engagement and sponsor oversight activities
  • You may act as Clinical Operations representative in Compound Development Teams
  • Requirements

  • A BSc or MSc level preferably within the medical, biological, pharmaceutical science or equivalent.
  • Minimum 7+ years’ experience with clinical trial management from a CRO and/or pharmaceutical company.
  • Experience within the field of oncology is preferred and/or First In Human trials
  • Proven skills from working in a project oriented and international organization.
  • 2+ years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable.
  • Excellent communication skills in English both written and spoken.
  • Moreover, you meet the following personal requirements:

  • You are a dedicated team player and enjoy leading teams and inspire trust among colleagues.
  • You have a quality mindset and able to prioritize your work in a fast paced and changing environment.
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

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