Senior Study Start-Up Specialist

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 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 centr…