Transformational Clinical Trial Planner

1 week ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we are committed to shaping the future of cancer treatment and serious diseases through innovative therapies and antibody products.

This is a newly created role in our Development Program Management team within the global Portfolio & Project Management (PPM) department. As a Sr. Manager Clinical Trial Planner, you will play a pivotal part in advancing transformative therapies to patients by managing clinical trials from initiation to final reporting, ensuring alignment with our Global Development Operations (Dev Ops) colleagues.

About the Role

  • You will construct and monitor clinical trial execution plans for assigned studies (Phase I-IV), utilizing project management tools like Microsoft Project.
  • Deliver comprehensive and integrated clinical trial execution plans (Phase I-IV) for Dev Ops commencing with project governance endorsement and steered through Clinical Study Report finalization.
  • Facilitate the crafting of clinical trial plans in sync with defined program timelines, ensuring cross-functional input and verification.
  • Engage in scenario planning to aid the trial management team in outlining the strategy for trial execution.
  • Collaborate with the Clinical Trial Teams to monitor the overall trial health and the delivery of clinical trial milestones.

Your Expertise

  • A minimum of a Bachelor's degree; preferred to be in a scientific or healthcare domain.
  • Minimum of 4 years of experience in a project or clinical trial management, with at least 3 years in the pharmaceutical or healthcare industry.
  • High-level comprehension of the end-to-end clinical trial planning and execution.
  • Highly proficient in MS Project and MS Office Suite.
  • Familiarity in the use of Clinical Trial Management System and Portfolio Management systems like Planisware is a plus for milestone and driver tracking.
  • Strong analytical acumen and confident communication ability to identify and report risks.
  • The ability to work independently with a high degree of accountability as well as work effectively in a collaborative team environment.
  • Demonstrated project management skills with a working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
  • Ability to negotiate and liaise with colleagues professionally and present to staff at all levels.
  • Financial acumen and ability to contribute to budget management.

What We Offer

  • An estimated salary of $120,000 - $160,000 per year, depending on qualifications and experience.
  • A dynamic and agile working environment that fosters collaboration and innovation.
  • A state-of-the-art laboratory and office spaces designed to connect employees and promote work-life balance.
  • The opportunity to work on cutting-edge projects and contribute to the development of life-changing therapies.

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