Study Start-Up Specialist

BeiGene, Ltd.; São Paulo; Híbrido; BRL 90 000 - 180 000; Tempo integral

Resumo da oferta

BeOne is seeking a Regulatory Start-Up Specialist in Sao Paulo, Brazil, to support study start-up and ongoing submissions under ICH/GCP.

You will work hybrid 2–3 days in the office, liaise with Ethics Committees and Regulatory Authorities, and manage documentation and timelines.

The role requires a Bachelor's degree in science, at least 2 years in clinical research, and fluent English; Spanish is a plus.

Qualificações

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 2 years of progressive experience in clinical research.
• Knowledge of ICH/GCP and local regulations.
• Proficient in document management and submission processes.

Responsabilidades

• Familiar with ICH/GCP and local regulations and SOPs.
• Support site feasibility and start-up activities to optimize timelines.
• Drive site start-up tasks from selection to activation.
• Prepare submission dossiers for Ethics Committees and Regulatory Authorities.
• Coordinate project timelines and ensure timely deliverables.
• Handle SSU data entry in CTMS if applicable.
• Translate or review regulatory documents as needed.

Conhecimentos

Fluent English

Strong written and verbal

Highly organized

Diligence in follow through

Formação académica

Bachelor’s degree or higher in a scientific/healthcare discipline

Ferramentas

Microsoft Office

Outlook

Word

Excel

PowerPoint

Teams

Descrição da oferta de emprego

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.

Global 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

Equal Opportunity Statement

We are proud to be an equal opportunity employer. BeOne 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. All employment is decided on the basis of qualifications, merit, and business need.

About BeOne

BeOne 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 committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland.

China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit