About us
BeiGene 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 BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
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 New Zealand working rights to be considered.
What We Offer To Our Valued Employees
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.
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.
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