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Study Start-Up Specialist

4 months ago

Sydney, Australia BeiGene Full time

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 10,000 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 RGOsubmissions

Clinical trial site contract and budget negotiation, if required

Prepare, submit regulatory documents to HGRAC and obtain approval for requiredstudy

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)

Full-time working from home

In-house and external learning and development opportunities

Fantastic benefits program as per the current policy including;

Personal health insurance reimbursement

Home-office setup allowance

Monthly reimbursement for home office expenses (i.e. internet, mobile..)

Group life insurance & income protection insurance

Wellness benefits (Employee Assistance Program)

Paid parental leave

And more as the benefit programs are keep improving

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: