Study start-up specialist – São Paulo/SP [híbrido]

Responsabilidades

• Support in the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations.
• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs.
• Conduct 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.
• Drive 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.
• 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, and Annual/Final reports to Regulatory Authority.
• 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.
• Perform the translation process for ethical and regulatory documents.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Fluent English required.
  • 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.
  • Intermediate skills in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams.
  • Travel: Up to 10%.
• QUALIFICAÇÕES PREFERENCIAIS
  • Spanish is a plus.
  • Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology.

Marcado como: Assuntos Regulatórios, Documentação, Indústria Farmacêutica, Oncologia, Pesquisa Clínica