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Senior Clinical Trial Manager

ICON Public Limited Corporation

Remote, Italy

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well

  • Accountable for day to day activities of all aspects for the management of local and/or regional company sponsored studies, as well as Global Phase IV studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Accountable for the oversight of the study, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
  • Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
  • Monitor study budget and timelines
  • Monitor work to ensure quality
  • Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
  • Contribute to the planning and set-up of a study and provide planning parameters
  • Support early access programs on the country level
  • Understanding of local / country and regional requirements for clinical trials
  • Managing and steering CROs
  • At least 5 years of experience in clinical research in a CRO, pharma or biotech company
  • Clinical Trial Management experience, CRA background preferred
  • Demonstrated good interpersonal skills
  • Demonstrated good written and verbal communication skills
  • Demonstrated good presentation skills
  • Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a
  • meaningful way
  • Analytical skills, quick perception and good judgment
  • Fluency in English (oral and written) plus local language

Job posted: 2024-05-09

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