Global Study Specialist (Kitchener)

Insight Global

📍 kitchener, region of waterloo, Canada

Full-time Other-General

Job Description

Must-Haves

  • 1+ year of clinical trial experience (pharma/life sciences)
  • Oncology clinical trial experience
  • Experience supporting clinical trials from start‑up through closeout
  • Strong documentation experience (eTMF / CTMS)
  • Experience working with CROs
  • Experience adhering to ICH‑GCP guidelines
  • Ability to manage multiple studies at different phases simultaneously
  • Experience meeting tight deadlines in a fast‑paced workplace
  • Submissions experience (regulatory / ethics committees)
  • Bachelor’s degree (life sciences or related)

Day-to-Day

  • Support clinical trials from start‑up through closeout
  • Manage and maintain study documentation (collect, review, track, organize)
  • Customize and manage Expected Document Lists (EDL)
  • Ensure proper TMF documentation, handoffs, and inspection readiness
  • Track document status, approvals, and deadlines acr...
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