北京招聘

? 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 Start up and Monitoring KPI’s trial objectives.
? In collaboration with COMs/PMs, reviews the status of planned versus actual patient recruitment and supports implementation of strategies to correct deviations from proposed plan enrolment according to monitoring procedures
? Enhance BeiGene 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 monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with local trainer.
? Is responsible for execution of co monitoring visit to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies in collaboration with COMs/PMs.
? Ensures adherence to clinical data standards, prevailing legislation,
GCP, Ethical Committee 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 Innovative Medicines 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 site 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
职位要求：
? Bachelors degree or higher in a scientific or healthcare discipline preferred
? 1 3 years or above of people management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
? Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
? Experience in project management and, 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 (CNDA), local/National Health Authorities regulations and BeiGene standards
? Strong written and verbal Communicate effectively with site personnel, country and global associates

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。