Study Start-up Specialist

BeiGene; São Paulo; Híbrido; BRL 120 000 - 170 000; Tempo integral

Resumo da oferta

BeOne is seeking an experienced Regulatory/SSU support professional for Sao Paulo with 2+ years in clinical research. The role involves coordinating study start-up, submissions, and regulatory activities in a hybrid Sao Paulo setting.

The ideal candidate has strong ICH/GCP knowledge, excellent communication, and is highly organized. Travel up to 10% and collaboration across the Americas are expected.

Qualificações

• 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
• Strong written and verbal communication skills
• Highly organized and diligent in follow through

Responsabilidades

• Support in delivery of study start-up, initial and ongoing submissions within established timelines
• Provide Regulatory support after approvals, including submission of core documents to sites and Regulatory Authority
• Complete SSU data entry in CTMS, if applicable
• Support in development of local workflows to streamline output and deliverables
• Contribute to improvement of SSU infrastructure in the Americas – U.S., Canada, and Latin America
• Translate regulatory documents as needed

Conhecimentos

ICH/GCP knowledge

Task prioritization

Written & verbal communication

Highly organized

Diligence

Formação académica

Bachelor's degree or higher in scientific/healthcare

Ferramentas

Microsoft Office

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.

Job Description

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

• Site Start-Up

• ICF/Submissions

• 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

#LI-Remote

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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.