CRM 上海/南京
BeiGene
Shanghai KCC
5天前

BeiGene 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 : 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 Qualification Required :
  • 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 Follow Us on MoSeeker!
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