- Location
- Seoul, Korea, Republic of
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Entry
- Source
- Workday
Description
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 and review, 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 if required.
Prepare, submit regulatory documents to RA and obtain approval for required study.
Assist CSMs in managing clinical trial during startup phase.
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 and review, 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 if required.
Prepare, submit regulatory documents to RA and obtain approval for required study.
Assist CSMs in managing clinical trial during startup phase.
Qualification Required:
Education Required:
Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
8 or more years of clinical research experience in the Pharmaceutical or CRO industry
Supervisory Responsibilities:
Provide ongoing mentoring and training to Start-up team specialist and Associate SSUM
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications:
Knowledgeable expert in the execution of clinical trials, expert understanding of GCP/ICH Guidelines and other applicable regulatory requirements
Recent start-up experience in Korea
Demonstrated experience working on a team across multiple functional areas for Associate Clinical Start-Up Manager
Excellent communication, relationship building and interpersonal skills
Excellent organizational skills and ability to prioritize multiple tasks
Self-motivation with the ability to work under pressure to meet deadlines
Fluent in English (writing and speaking)
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.
