天津招聘

       1) Lead study level feasibility conduction to time and quality; Work with Medical Affairs Manager/Physicians on the planning for study budget, timeline, recruitment target and outsourcing 

       2) Cooperate with CROs to track, oversee and manage to agreed study timelines, budget and take appropriate actions to get study on track if any issues

       3) Responsible for study quality; Work with CRM to develop and implement of co-monitoring & QA plan before the study start and ensure no significant compliance( GCP, SOP or applicable regulations) issue during the whole study conducted by CROs; Review study agreement with CRO

       4) Ensure the quality of CRO together with CRM and MA physicians on study operations such as Study documents such as protocol, ICF and CRF design; Site selection by balancing both business and quality study needs through cross function work; organize and follow up investigator meetings; Plan, order and track clinical supply; ensure clinical supply met study conduction demands to quality and timely; Perform initiation, monitoring and study close out tasks as required by GCP and SOPs

       5) Ensure the eTrack data completeness and accurate during the whole study conduction

       6) Work with CRM to generate and manage local SOPs relevant to clinical research

       7) Track and manage all studies conducted in Medical Affaire including timeline, budget and present status