Oncology Clinical Trial Specialist
I
Insight Global
📍 kitchener, region of waterloo, Canada
Job Description
Join a dynamic team as an Oncology Clinical Trial Specialist, leveraging your clinical trial experience to support essential research projects. This role focuses on managing documentation and coordinating trials from start-up to closeout.
This position requires a candidate with at least one year of clinical trial experience within the pharma/life sciences sector, specifically in oncology. You will oversee documentation across various studies, ensuring compliance with ICH-GCP guidelines while managing multiple projects simultaneously in a fast-paced environment. Strong communication skills are a must, especially when coordinating with CROs, investigators, and vendors.
Key Responsibilities:
• Support clinical trials from initiation through closeout
• Manage and organize critical study documentation
• Customize and oversee Expected Document Lists (EDL)
• Ensure inspection readiness and proper TMF documentation
• Assist with regulatory and ethics submission processes
This position requires a candidate with at least one year of clinical trial experience within the pharma/life sciences sector, specifically in oncology. You will oversee documentation across various studies, ensuring compliance with ICH-GCP guidelines while managing multiple projects simultaneously in a fast-paced environment. Strong communication skills are a must, especially when coordinating with CROs, investigators, and vendors.
Key Responsibilities:
• Support clinical trials from initiation through closeout
• Manage and organize critical study documentation
• Customize and oversee Expected Document Lists (EDL)
• Ensure inspection readiness and proper TMF documentation
• Assist with regulatory and ethics submission processes