QC inventory coordinator supporting Apotex, a Canadian pharmaceutical company producing affordable medicines. Managing laboratory samples, standards, inventory, purchasing, compliance, and training activities.
About the role
- Senior Study Start-Up Specialist managing clinical trial submissions, site activation, and essential documents for BeOne’s oncology-focused operations in Canada.
Responsibilities
- Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations
- Contribute to discussions during the feasibility stage of site selection
- Drive kick-off and completion of tasks from selection through activation, including providing timeline input for site activations
- Leverage and build upon existing site partnership data to execute start-up efficiently and reduce cycle times
- Manage document preparation, negotiation, and submission to achieve submission targets from start-up through close-out
- Prepare and submit documents to central IRB to ensure timely reviews
- Ensure collection and review of essential documents
- Complete SSU data entry in CTMS
- Complete timely and quality eTMF filing
- Support development of local workflows to streamline output and deliverables
- Contribute to ongoing improvement of SSU infrastructure in North America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Requirements
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 3 years of progressive experience in clinical research and clinical operations, preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment
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