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Study Start-Up Specialist

2 meses atrás

São Paulo, São Paulo, Brasil BeiGene, Ltd. Tempo inteiro
About BeiGene, Ltd.

BeiGene, Ltd. is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics.

Job Summary

We are seeking a highly motivated and experienced Study Start-Up Specialist to join our team. The successful candidate will be responsible for supporting 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.

Key Responsibilities
  • Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
  • Site Feasibility
    • Build knowledge in therapeutic area, local regulations 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.
      • Prepare submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions.
      • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
    • 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 review of essential documents
      • Provide Regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority. Supply Regulatory Authority with Annual/Final reports.
      • Complete SSU data entry in CTMS, if applicable
      • 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.
      • Support vendors qualification until final setup in LATAM. May act as point of contact with vendors for issues/alignment.
      • Perform the translation process for ethical and regulatory documents.
    Requirements
    • Bachelor's degree or higher in a scientific or healthcare discipline preferred with minimum of 2 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
    • 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
    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
    About Us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.