Be a key player in clinical research with BeOne as a Senior Clinical Study Start-Up Specialist, working remotely from Canada. Drive efficient study start-up processes while ensuring compliance with industry regulations. In this essential full time role, your responsibilities will span across managing study submissions and enhancing site activation timelines.
You will utilize your 3+ years of experience in clinical operations, leveraging ICH/GCP knowledge and improving workflows. Your efforts directly contribute to the ongoing fight against cancer through innovative research solutions. Key Responsibilities:
- Coordinate study start-up processes and site selection
- Drive rapid completion of tasks from selection through activation
- Manage document preparation for central IRB submission
- Ensure accurate data entry and filing in CTMS and eTMF
- Assist in optimizing local workflows for better outputs Requirements:
- Bachelor's degree or higher in a scientific field
- Minimum 3 years in clinical research environments
- Understanding of ICH/GCP and country regulations
- Strong ability in document management and negotiation
- Experience in biotech, pharmaceutical, or CRO settings Empower clinical trials with your expertise at BeOne.