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 schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.Join us and Make momentum in your career!

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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates 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.