Study Start-up Specialist

BeiGene, Ltd.; São Paulo; Híbrido; BRL 100 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Resumo da oferta

BeiGene, Ltd. is seeking a Study Start-up Specialist to support the delivery of study start-up and submissions across established timelines in accordance with ICH/GCP, BeOne SOPs, and local regulations.

The role requires collaboration with sites, ethics committees, and regulatory authorities to ensure efficient activation and ongoing compliance. The candidate will manage essential documents, contribute to local workflows, and support SSU infrastructure improvements in the Americas, including the

Qualificações

• Bachelor’s degree or higher in a scientific or healthcare discipline.
• Minimum 2 years in clinical research/operations.
• Experience in biotech/pharma is preferred.

Responsabilidades

• Support start-up delivery and submissions per timelines.
• Coordinate with Ethics Committees and Regulatory Authorities.
• Drive site activation and start-up tasks.
• Maintain CTMS data entry and regulatory documents.

Conhecimentos

Fluent English

Spanish language

Strong organizational skills

Excellent communication

Formação académica

Bachelor’s degree in science/healthcare

Ferramentas

MS Office Suite

Descrição da oferta de emprego

## Study Start-up SpecialistApplylocations: São Paulotime type: Full timeposted on: Posted Todayjob requisition id: R35844BeOne 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**PLEASE SUBMIT ALL RESUMES/CV'S IN** ENGLISH **FOR CONSIDERATION**Language Requirement**:** Fluent English required. Spanish is a plusPreferred Experience**:** Pharmaceutical/Biotech Industry, Hematology, OncologyLocation**: 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 regulationsEssential 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 documentsMinimum 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 environmentOther 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 throughSupervisory Responsibilities: NATravel: Up to 10%Computer Skills:Intermediate skills in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams**#LI-Remote**Global CompetenciesWhen 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 ClarityWe 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.