Australia Job Openings
BeiGene
Study Start-Up Specialist
FULL TIME
August 30, 2024
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Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP
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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,
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Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study
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Prepare IRB/HREC and RGO submissions
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Clinical trial site contract and budget negotiation, if required
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Prepare, submit regulatory documents to HGRAC and obtain approval for required study
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Assist in maintain and update company-level investigator database
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Establish, maintain and enhance relationship with key opinion investigators and sites
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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
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Perform other duties as assigned by management
Qualification Required:
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Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
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Knowledgeable in the execution of clinical trials, understanding of GCP/ICH Guidelines and other applicable regulatory requirements
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At least one year of clinical research experience in the Pharmaceutical or CRO industry
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Self-motivation with the ability to work under pressure to meet deadlines
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Fluent in English (writing and speaking)
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Full working rights in Australia (Citizen or PR)
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What we offer to our valued employees:
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Market competitive compensation package including performance-based annual bonus scheme
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Company shares (generous welcome grant and performance-based annual equity plan!)
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Full-time working from home
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In-house and external learning and development opportunities
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Fantastic benefits program as per the current policy including;
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Personal health insurance reimbursement
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Home-office setup allowance
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Monthly reimbursement for home office expenses (i.e. internet, mobile..)
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Group life insurance & income protection insurance
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Wellness benefits (Employee Assistance Program)
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Paid parental leave
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And more as the benefit programs are keep improving!
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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.Bei Gene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. Bei Gene 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. -
- 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
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