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BeiGene

via Workday

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Study Start-Up Specialist

Anywhere
full-time
Posted 9/25/2025
Direct Apply
Key Skills:
Clinical Research
ICH/GCP
Document Management
Submission Preparation
Site Relationships
Data Entry
Workflow Development
Organizational Skills
Communication Skills
Task Prioritization
Diligence
Teamwork
Analytical Thinking
Continuous Learning
Initiative
Entrepreneurial Mindset

Compensation

Salary Range

$71K - 96K a year

Responsibilities

Support in the delivery of study start-up and ongoing submissions within established timelines. Ensure compliance with ICH/GCP, BeiGene SOPs, and local regulations while driving efficiency in the start-up process.

Requirements

A bachelor's degree in a scientific or healthcare discipline is preferred, along with 3+ years of experience in clinical research. Candidates should possess strong communication skills and be highly organized.

Full 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. 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, BeiGene SOPs, and local regulations. Essential Functions of the job: Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs 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. 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 in the collection and review of essential documents Complete SSU data entry in CTMS 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 Supervisory Responsibilities: Not applicable Computer Skills: Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams Education/Experience Required: Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 3+ years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment. Other Qualifications: 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 Travel: Up to 10% 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 Salary Range: $71,400.00 - $96,400.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com. 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

This job posting was last updated on 9/26/2025

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