Clinical Research Manager position at BeOne Medicines.| Japan

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BeOne Medicines Clinical Research Manager

Experience: 6-years

Pattern: full-time

Country:

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Associate

Japan....Japan

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: General Description: The Clinical Research Manager (CRM) is responsible for the hiring, training, competency development and assignment of CRAs to ensure qualified study implementation. The CRM is responsible for CRA (trial monitoring and external) quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct (recruitment, quality data collection, issue resolution and site management). The CRM is responsible for CRA performance to KQI’s, ensuring implementation and appropriate application of established monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations. The CRM is responsible for site engagement which is focusing on building relationship with study coordinator managers to identify site staff’s needs for the studies and establish positive company reputation. Essential Functions of the job: Allocation, initiation and conduct of trials Allocate CRA resource in new trials in collaboration with Start-up and Clinical Monitoring teams. Ensures trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Monitoring KPI’s trial objectives. In collaboration with CSMs, reviews the status of planned versus actual patient recruitment and supports implementation of strategies to correct deviations from proposed plan Enhance BeOne relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring Delivery of quality data and compliance to quality standards Is accountable for monitoring quality and issue resolution through timely review and support the approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolution Ensures CRA competency gaps are identified and resolved through targeted training curricula in collaboration with local trainer. Is responsible for execution of CRA Assessment visit to evaluate ongoing CRA monitoring competency, identifying issues and developing resolution strategies in collaboration with CSMs. Ensures adherence to clinical data standards, prevailing legislation, GCP, Institutional Review Board/Ethical Committee(IRB/EC) and SOP requirements Supports site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues Manages CRA adherence/compliance to SOPs and required training curricula Management of people and resources management Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Phase I-IV trials. Performs ongoing assessment and allocation of monitoring resources within study team to ensure balanced CRA workload for quality monitoring Ensures CRAs have the required level of Monitoring area knowledge and skills to successfully deliver to protocol requirements Is responsible for managing and addressing CRA performance and quality performance indicators, including managing timely site activation, recruitment commitments, timely data entry and issue resolution Budget and productivity Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure within local targets for monitoring visits budget (as appropriate) Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts Adheres to and contributes to the development and review of Working Instructions and SOPs, if required Description for focusing on Japan: Supports Senior Director to build Japan organization and required process such as Local SOP and WI. Conducts Country level feasibility. Supports country activity for new studies until regional/ country CSM is identified. Vendor management for FSP partners and dispatching staffs in Japan. Takes trial management responsibility if required. Conducts Site Motivation visits and Site Engagement Visit in Japan. Prepares and supports PMDA inspection Other tasks, if needed. Supervisory Responsibilities: Provides mentoring and oversight of team members and CRAs Provides necessary training to CRAs, support site visits as needed Performs CRA Assessment Visits and co-monitoring visits with CRAs if needed to ensure oversight and address site related concerns Assists with the identification of development opportunities for team members Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback as well as oversight of subordinate team’s performance Qualification Required: Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook Education Required: Bachelors degree or higher in a scientific or healthcare discipline preferred A minimum of 5-6+ years of relevant clinical operations experience. Other Qualifications: Associate CRM: 1-3 years of people management or project management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field CRM: 3 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field Senior CRM: 5 years or above of people management and project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field CRM/Senior CRM: Solid understanding of career development and performance management activities Documented training, knowledge and application of current Regulations, GCP and ICH guidelines in clinical trials required Evidence of team leadership capabilities Therapeutic or medical knowledge preferred Exhibits a strong understanding of methodologies and approaches Understanding of all aspects of monitoring and trial execution Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues. Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, local/National Health Authorities regulations and BeiGene standards Strong written and verbal communicate effectively with site personnel, country and global associates Computer skills including proficiency in use of Microsoft office, Excellent organization skill and management of competing priorities Travel: up to 30-40% time, as required What We Offer To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan!) 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 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 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 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.

Clinical Research Manager job opportunity at BeOne Medicines.

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