CRA II

BeOne Medicines; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

BeOne Medicines is seeking a Clinical Research Associate (CRA) to monitor Oncology and Hematology trials in Malaysia. You will perform site initiation, data collection, and closeout activities in line with GCP/ICH and local regulations.

Join a global oncology company advancing affordable treatments. You’ll conduct monitoring visits, prepare reports, and collaborate with investigators to ensure timely, high-quality data across sites.

Qualifications

• Bachelor’s degree or above in life sciences, pharmacy, nursing or medical.
• +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry.
• Fluent in English (writing and speaking).

Responsibilities

• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit).
• Co-monitoring visits, if required.
• Ensures study milestones for sites responsible are met as planned (startup, recruitment, database analyses, closeout).
• 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.

Job description

About Us

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.

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.

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)

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