Global Study Specialist (Kitchener)
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Insight Global
📍 kitchener, region of waterloo, Canada
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...