Study Start-up Specialist

BeOne Medicines; São Paulo; Híbrido; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

BeOne Medicines in Sao Paulo is seeking an experienced clinical operations professional to support study start-up and ongoing submissions in line with ICH/GCP guidelines. The role requires collaboration with regulatory teams, sites, and internal stakeholders to ensure timely, high-quality deliverables.

Minimum 2 years in clinical research within biotech/pharma, with a Bachelor’s degree or higher in a scientific or healthcare discipline.

Qualificações

• Knowledge of ICH/GCP guidelines and local regulatory requirements.
• Experience coordinating regulatory submissions and site start-up activities.
• Excellent written and verbal communication, with cross‑functional collaboration.
• Ability to prioritize tasks to meet timelines and quality standards.

Responsabilidades

• Support in delivery of study start‑up, initial and ongoing submissions within established timelines.
• Drive site feasibility and select/activate first sites to achieve first patient initiation.
• Prepare submission dossiers for Ethics Committees and regulatory authorities.
• Review and establish project planning and timelines for efficient delivery.
• Provide regulatory support post‑approvals and year‑end reports to authorities.

Conhecimentos

ICH/GCP knowledge

Regulatory strategy

Strong communication

Prioritization

Formação académica

Bachelor’s degree or higher in science/healthcare

Ferramentas

Microsoft Office (Outlook, Word, Excel, PowerPoint)

Descrição da oferta de emprego

Job Description

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 prospective first site(s) to be selected/activated to achieve first patient initiation (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 submission 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 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 sites and regulatory authorities, and Annual/Final reports to regulatory authority.
  • Complete SSU data entry in CTMS, if applicable.
  • Support 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 translation of ethical and regulatory documents.

Minimum Requirements – Education And Experience

Bachelor’s degree or higher in a scientific or healthcare discipline preferred with a minimum of two 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 to achieve 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

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.