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 8,500 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.
Job Description:
The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country.
The CRA is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
How you will add value:
Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
Conducts co-monitoring visits, if required
Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
Attends onboarding-, disease indication and project specific training and general CRA training as required
Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
Conducts Quality Oversight Visits (QOV), as requested
Completes monitoring visit/ QOV reports timely
Assists with investigator/site identification
Assists site to prepare Ethics Committee submissions
Facilitates clinical trial site contract and budget negotiation
Manages site queries and communications
Assists in managing clinical trials, if required
Establishes regular lines of communication with sites and COMs
Provides protocol and related study training to assigned sites
Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
Performs additional task as assigned
Qualification Required:
What we expect from the successful candidate:
Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
+1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Fluent in English (writing and speaking)
Applicant must have full Australian working rights to be considered.
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)
Active social club
And more as the benefit programs 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:
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.
Covid-19 policy:
As part of the job requirements, all site-facing roles (i.e. a role that requires attendance at clinical sites as part of their job) are required to be fully vaccinated for COVID-19, according to their current clinical site health and safety protocol.
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