• Study Start-Up Specialist

    BeOne Medicines (Emeryville, CA)


    General Description:

    + Support in the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.

    Essential Functions of the job:

    + Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs

    + 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.

    + Support in the 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

    Supervisory Responsibilities:

    Not applicable

    **Computer Skills:** Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

    Education/Experience Required:

    Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 3+ years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

    Other Qualifications:

    + Knowledge in the execution of clinical trials, understanding of ICH/GCP

    + 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.