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Global Trial Specialist

2 weeks ago


Halifax, Nova Scotia, Canada ICON Full time

About Our Company

ICON is a leading provider of clinical research services, with a global presence and a reputation for delivering high-quality results. We are committed to fostering a culture of innovation, collaboration, and continuous learning.

Job Description

We are seeking a highly skilled Clinical Research Associate to join our team and contribute to the success of our projects. The successful candidate will be responsible for overseeing multiple oncology trials, providing leadership and mentorship to junior team members, and ensuring compliance with Good Clinical Practice (GCP).

Responsibilities

  • Oversee multiple oncology trials, ensuring timely and accurate execution
  • Provide leadership and mentorship to junior team members, promoting a culture of excellence and collaboration
  • Act as Lead Site Manager, training and guiding other site managers on study protocols and best practices
  • Develop essential study start-up documents, including SIV agendas and ensure compliance with Good Clinical Practice (GCP)
  • Represent Site Managers and Lead Trial Managers in key meetings, advocating for the needs and perspectives of site staff
  • Ensure the site manager perspective is reflected in study documents, such as Monitoring Guidelines
  • Review reports (SQV, SMV, SCV) for sites assigned to other site managers within the same trial, identifying areas for improvement and implementing corrective actions
  • Support country budget development and contract negotiations in collaboration with CCS colleagues
  • Assist with ASV activities and ensure alignment with study objectives
  • Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

Qualifications

  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
  • At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
  • Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
  • Knowledge of risk-based/analytical monitoring approaches is an asset
  • Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Strong collaboration with investigators and site staff to meet study timelines
  • Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
  • Ability to work independently while being a strong collaborator
  • In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements