**General Description:**

+ 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.

**Essential Functions of the job:**

+ Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
+ Contribute to discussions during the feasibility state of site selection
+ Site Start-Up
+ Skilled in driving 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, reducing cycle times wherever possible.
+ ICF/Submissions
+ Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
+ Skilled in document preparation and submission to central IRB to ensure timely reviews.