Senior CRA

🕒 October 14

🇲🇾 Malaysia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Perform monitoring activities for initiation, conduct, recruitment, quality data collection, and timely completion of Oncology and Hematology clinical trials within Malaysia • Deliver data within timelines and required quality standards • Ensure adherence to monitoring procedures in accordance with GCP, ICH, local regulations, and SOPs • Conduct pre-study, initiation, routine monitoring, closeout, co-monitoring, and Quality Oversight Visits as required • Ensure study milestones are met, including study startup, recruitment, database analyses, and closeout • Document monitoring activities and complete monitoring/QOV reports timely • Assist with investigator/site identification and Ethics Committee submissions • Facilitate clinical trial site contract and budget negotiation • Manage site queries and communications • Provide protocol and study training to assigned sites • Evaluate site practices and escalate quality issues as appropriate • Track regulatory submissions, recruitment, CRF completion, and data query resolution • Collaborate with the CRA Group/CRM on recruitment and contingency plans • Perform additional assigned tasks

🎯 Requirements

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medicine • Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines • +1 year of monitoring experience in the pharmaceutical or CRO industry; over 4 years for SCRA • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Fluent in English (writing and speaking)

🏖️ Benefits

• 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 • Dynamic, collaborative, supportive, inclusive, and fun team environment

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