北京招聘

Purpose of Job
The Clinical Research Manager is responsible for the hiring, training, development and assignment of CRAs to ensure qualified Monitoring resource assignment to the Drug Development portfolio.
? The Clinical Research Manager 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).
? The Clinical Research Manager 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.
Major Responsibilities
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。