Regional Clinical Trial Management Associate

About us

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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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:

General Description:

• Key Clinical Operations support role; ensures that delegated components of clinical trials are executed to expected and specified quality standards
• Builds basic knowledge of clinical trials operations and scientific principles and objectives of BeiGene’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
• Learns best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations

Description for focusing on Japan:

• Support to build Japan organization and required process such as Local SOP and WI.
• Support regional CSM for Japan specific regulations and tasks.
• Supports PMDA inspection
• Other tasks, if needed.

Essential Functions of the job:

• Organize Clinical Operations department meeting/teleconference
• Write meeting minutes, if required
• Maintain department files
• Update department trackers
• Assist in preparing/update clinical trial related tracking/slides
• Assist in clinical trial related printing, shipment, purchasing and contract signature and all the administrative work.
• Assist CTMS management
• Assist CRA activities for SIV and COV
• eTMF submitter (document management, overdue check and QC f/u)
• Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies
• Local Vendor Registration support
• Customer clearance to import IP and lab kit
• SUSAR and other safety report submit to the local IRB and PI/ Site Director
• Support payment for the investigational fee and study related cost.

Supervisory Responsibilities:

Provides performance feedback on team members as required

Qualification Required:

Education Required: BS in a relevant scientific discipline preferred.

Computer Skills: Efficient in Microsoft Word, Excel, Outlook and other common software.

Other Qualifications:    

• Fluent in English (listening and writing)
• Excellent organizational skills and ability to prioritize and multi-tasks
• 2 years or above in clinical or drug development in the biotech/ pharmaceutical/CRO industry or the relevant clinical research field

Travel:  potential travel of up to 10%

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.