Associate Study Start-up Manager/Clinical Start Up Manager

Posted Yesterday
Be an Early Applicant
Seoul, KOR
In-Office
Senior level
Biotech
The Role
Lead clinical study start-up activities, including investigator and site identification, feasibility assessments, IRB and regulatory submissions, essential document preparation, informed consent finalization, site contract and budget negotiation, subject compensation and insurance review, and recruitment material localization. Ensure timelines, cost, quality, and ICH/GCP compliance while mentoring start-up specialists and collaborating across functions.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree or higher in life sciences, pharmacy, nursing, or medicine
  • 8 or more years of clinical research experience in the pharmaceutical or CRO industry
  • Expert knowledge of clinical trial execution, ICH/GCP guidelines, and applicable regulatory requirements
  • Recent clinical study start-up experience in Korea
  • Demonstrated experience working across multiple functional areas
  • Fluent English communication skills, written and spoken
  • Excellent communication, relationship-building, and interpersonal skills
  • Excellent organizational skills and ability to prioritize multiple tasks
  • Self-motivation and ability to work under pressure to meet deadlines
  • Proficiency with Microsoft Word, Excel, MS Project, PowerPoint, and Outlook

BeiGene Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BeiGene and has not been reviewed or approved by BeiGene.

  • Equity Value & Accessibility Equity grants and stock programs are widely available across roles, including RSU grants at hire and opportunities to participate in company equity plans. Total compensation commonly includes equity alongside base pay and incentives.
  • Healthcare Strength Health coverage is described as comprehensive and high quality, with multiple mentions of “top notch” medical benefits. This strength is consistently highlighted as a key component of the package.
  • Retirement Support Retirement offerings include a 401(k) with a competitive employer match. These features contribute to a strong overall compensation bundle.

BeiGene Insights

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The Company
HQ: Cambridge, MA
2,862 Employees
Year Founded: 2010

What We Do

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more 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 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal. See our community guidelines: bit.ly/39o3O6j

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