**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 SOPs, and local regulations. **Essential Functions of the job:** + Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs + Site Feasibility + Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed. + Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI. + Site Start-Up + Skilled in driving kick-off and completion of tasks from selection through activation. + 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. + Ensure collection and review of essential documents + Complete SSU data entry in CTMS + Support in the development of local workflows to streamline output and deliverables + Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America + Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals **Computer Skills:** Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams **Qualifications:** + Bachelor’s degree or higher in a scientific or healthcare discipline preferred + Minimum of 4 years w/BA or 6+ w/o of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment. + Knowledge in the execution of clinical trials, understanding of ICH/GCP + Effective prioritization of tasks in the achievement of goals + Strong written and verbal communication skills + Highly organized + Diligence in follow through **Travel:** Up to 10% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.