Associate Study Start-up Specialist

BeOne Medicines

São Paulo Onsite Clinical Operations

About this role

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.

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

Language Requirement: Fluent English Required

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid

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 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 1 year 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: N/A

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.