Study Start-up Specialist

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English required. Spanish is a plus

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid (2 to 3 days per week in the office)

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, BeOne SOPs, and local regulations

Essential Functions:

• 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, 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

Minimum Requirements – Education and Experience:

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

Other Experience:

• 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

Supervisory Responsibilities: NA

Travel:   Up to 10%

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

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