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$71,400.00 – $96,400.00

Study Start-Up Specialist

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Full-time Remote 6d ago

Location:

US

Company:

BeOne Medicines Ltd. is a global oncology company dedicated to developing affordable and innovative cancer treatments.

Summary:

The applicant will support study start-up processes and ensure compliance with regulations. A Bachelor’s degree and clinical research experience are required for the role.

Requirements:

Technology: Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

Hard Skills: Knowledge in the execution of clinical trials, Strong written and verbal communication skills, Highly organized

Credentials: Bachelor’s degree

Experience: 3+ years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Job 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 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.

  • 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 skills in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

Qualifications:

  • 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%