ICON plc

Trial Manager – Oncology

ICON plc

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Job Level

JuniorMid-Level

Tech Stack

Google Cloud Platform

About the role

  • The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes.
  • The L-LTM will serve as the country-level single point of contact on the study for internal partners.
  • While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks.
  • Manage and oversee Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…), including vendor purchase orders, invoice review and approval, and change-orders.
  • Execution of local milestones from feasibility through study close out.
  • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager.
  • Inspection Readiness and AQR at the country level.
  • Close collaboration with LTMs, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training.
  • Efficient communication with Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence.
  • Country level ad hoc meetings during any phase of the study to address unexpected circumstances.
  • Close partnership with the study Functional Manager to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation such as storyboards, lessons-learned, metrics, etc.

Requirements

  • BA/BS degree. Degree in a health or science related field.
  • 2 years of local trial management experience requied.
  • Start-up & Database Locks/Cleaning experience preferred
  • Cross therapeutic area trial management experience required.
  • Oncology trial management experience required, Early Development experience an asset.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations (i.e. Canadian), REB submissions, assigned protocols and associated protocol specific procedures.
  • Strong IT skills in appropriate software and company systems.
  • Willingness to travel with occasional overnight stay away from home according to business needs.
  • Proficient in speaking and writing the country language and English.
  • Good written and oral communication skills as appropriate
  • To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status