This is a fully remote position, open to applicants in Canada.

📋 Description

• Accountable for the timely delivery of study start-up, initial and ongoing submissions, ensuring high quality and compliance with ICH/GCP, BeOne’s SOPs, and local regulations.

• Participate in discussions during the feasibility phase of site selection.

• Facilitate the kick-off and completion of tasks from selection to activation, including providing timeline insights for site activations.

• Utilize and enhance existing site partnership data to execute start-up efficiently and minimize cycle times.

• Oversee document preparation, negotiation, and submission to meet submission goals from start-up to close-out.

• Prepare and submit documents to the central IRB to ensure timely reviews.

• Guarantee the collection and review of essential documents.

• Complete SSU data entry in the CTMS.

• Ensure timely and accurate eTMF filing.

• Assist in developing local workflows to optimize output and deliverables.

• Contribute to the continuous enhancement of SSU infrastructure in North America.

• Execute additional tasks as assigned or needed to meet project, functional, departmental, or corporate objectives.

⛳️ Requirements

• Knowledgeable in ICH/GCP, applicable country regulations/guidelines, and SOPs.

• A Bachelor’s degree or higher in a scientific or healthcare field is preferred.

• At least 3 years of progressive experience in clinical research and clinical operations, ideally within the biotech, pharmaceutical sector, CRO, or clinical site environment.