Study Start-Up Specialist

at  BeiGene

BeiGene 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:
About the Company:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.
BeiGene 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

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

Major Responsibilities

• 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 IRB/HREC and RGO submissions
• Clinical trial site contract and budget negotiation, if required
• Prepare, submit regulatory documents to HGRAC and obtain approval for required study
• 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
• Perform other duties as assigned by management

Qualification Required:

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
• Knowledgeable in the execution of clinical trials, understanding of GCP/ICH Guidelines and other applicable regulatory requirements
• At least one year of clinical research experience in the Pharmaceutical or CRO industry
• Self-motivation with the ability to work under pressure to meet deadlines
• Fluent in English (writing and speaking)
• Full working rights in Australia (Citizen or PR)
• 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 as per the current policy
• Plus you get to work with a dynamic team of collaborative, supportive, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we.BeiGene is proud to be an Equal Opportunity Employer:

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
BeiGene 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

BeiGene 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 BeiGene’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 BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (
https://www.beigene.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) BeiGene’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) BeiGene’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

• 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 IRB/HREC and RGO submissions
• Clinical trial site contract and budget negotiation, if required
• Prepare, submit regulatory documents to HGRAC and obtain approval for required study
• 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
• Perform other duties as assigned by managemen