Study Start-Up Specialist /Senior Study Start-Up Specialist

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:

• Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP

Essential Functions of the Job:

• Independently or under supervision of line manager lead Start-up specialist to the delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,

  • Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study.

  • Prepare, review, submit and QC submissions to Institution Review Board (IRB) to obtain clinical trial authorizations and approvals

  • Prepare, review, and approve site level critical documents for IP release.

  • Develop and finalize Country and Site-Specific ICFs.

  • Perform site contract/ budget negotiation during start-up and maintenance phase. (If required)

  • Review and finalize subject compensation rule and insurance as per local regulations.

  • Review and translate subject recruitment materials as per local regulations f required.

  • Prepare, submit regulatory documents to RA and obtain approval for required study.

  • Assist CSMs in managing clinical trial during startup phase.

• Assist in maintain and update company-level investigator database.

• Establish, maintain and enhance relationship with key opinion investigators and sites.

• Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside start-up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans.

• 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 BeOne studies.

• Perform other duties as assigned by management

Qualification Required:

Education Required:

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical

• At least 6 years of clinical research experience in the Pharmaceutical or CRO industry

Supervisory Responsibilities:  NA

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

•      Knowledgeable in the execution of clinical trials, understanding of GCP/ICH Guidelines and other applicable regulatory requirements

•        Self-motivation with the ability to work under pressure to meet deadlines

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!)

• 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 in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year 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.