(Senior) CRA

BeiGene, Ltd.; Malaysia; Remoto; MYR 73.000 - 106.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus program

Employee shares

Learning opportunities

Benefits program

Descrizione del lavoro

BeOne is seeking a Clinical Research Associate (CRA) to perform monitoring activities for Oncology and Hematology trials in Malaysia. You will ensure data quality, timelines, and adherence to GCP and local regulations across sites.

The role requires a life sciences degree, monitoring experience, and fluent English; you will participate in site onboarding, training, and protocol dissemination while coordinating with CI/CRM teams.

Competenze

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical.
• Over 4 years for SCRA; otherwise 1 year minimum monitoring experience in pharma or CRO.
• Fluent in English (writing and speaking).

Mansioni

• Conduct monitoring visits (pre-study, initiation, routine, closeout).
• Conduct co-monitoring visits if required.
• Ensure site milestones are met (startup, recruitment, data analyses, closeout).
• Provides protocol and site training to assigned sites.

Conoscenze

Communication skills

Organizational skills

Multitasking

English fluency

Formazione

Bachelor’s degree or above in life sciences

Descrizione del lavoro

About us

BeOne 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 BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne 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.

BeOne 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 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland.

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

• 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)

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)
• In-house and external learning and development opportunities
• Fantastic 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!

BeOne Global Competencies

• 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

Patients First Driving Excellence Bold Ingenuity Collaborative Spirit

Privacy Policy

BeOne 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 BeOne’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 BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.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) BeOne’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) BeOne’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.

China Mainland Job Posting

At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.