Job Information
BeOne Medicines Senior Study Start-Up Specialist in Durham, North Carolina
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.
Ensure collection and review of essential documents
Complete SSU data entry in CTMS
Complete timely and quality eTMF filing
Support in the development of local workflows to streamline output and deliverables
Contribute to the ongoing improvement of SSU infrastructure in North America
Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Supervisory Responsibilities :
- Not applicable
Education/Experience Required:
Bachelor’s degree or higher in a scientific or healthcare discipline preferred
Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
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.