BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.
General Description:
The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. May be assigned to CRA activities or start-up activities, depending on experience and project needs Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region. Identify gaps and areas for improvement and propose CAPA. Supports start-up and provides local expertise. The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
CRA activities
Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets Provides protocol and related study training to assigned sites. Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs Conducts co-monitoring visits, if required Completes monitoring visit reports in accordance with ICH-GCP, BeiGene standards and SOP Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations Ensure inspection readiness of the study and sites Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) Attends disease indication project specific training and general CRA training as required Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Computer Skills:Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook Other
Qualifications:
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
Ideally2+ years of (CRA) 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)
Travel:up to 60%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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
