Senior Study Start-Up Specialist

BeiGene

1d•$83,800 - $113,800•Remote

About The Position

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. This role involves driving the kick-off and completion of tasks from site selection through activation, managing document preparation and submission to central IRB, and ensuring the collection and review of essential documents. The specialist will also be responsible for data entry in CTMS, eTMF filing, and contributing to the development of local workflows and the improvement of SSU infrastructure in North America. Additional tasks may be assigned to achieve project, functional, departmental, or corporate goals.

Requirements

Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs.
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.
Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
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.
Global Competencies: Fosters Teamwork, Provides and Solicits Honest and Actionable Feedback, Self-Awareness, Acts Inclusively, Demonstrates Initiative, Entrepreneurial Mindset, Continuous Learning, Embraces Change, Results-Oriented, Analytical Thinking/Data Analysis, Financial Excellence, Communicates with Clarity.

Nice To Haves

Contribute to discussions during the feasibility state of site selection.

Responsibilities

Drive 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.
Manage 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.