天津招聘

职位描述：
This position will support the operational aspects of all GCDO managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and disclosure). He/she will work in support of the GCDO Program Leader (GPL), GCDO Trial Leader (GTL) and Clinical Trial Manager (CTM) to track study timelines and trial budget, to support protocol and country feasibility, site selection, and trial and vendor set-up, study execution and trial closure related activities.
Responsibilities include but are not limited to generation of progress tracking reports, analysis and follow-up, trial specific system set-up and access management, system data entry, setting up meetings and maintaining minutes, document management and investigator meeting set-up and coordination.
This position will report into a DOCS Operations Manager or DOCS GCDO Functional Manager with dotted line matrix reporting structure with designated GCDO trial team members.
Internal contacts at client include but are not limited to:
GCDO Operations Head, Clinical Trial Manager, GCDO Trial Leader, GCDO Program Leader, Functional Management, other GCDO-CTAs, Local Trial Manager, Country-based - CTAs, Site Manager, IDM Manager, Central Monitoring Managers, HCC Clinical Operations Services, cross functional members of the trial team: Study Responsible Physician/Scientist, Global Data Manager, Statistical Programmer, Biostatistician, Regulatory Medical Writer, Clinical Trial Registry Lead, Trial Supply Manager, Quality and Compliance Manager, Quality Process Lead, Business Operations Manager, Procurement Services and Functional Planner
External Clients: vendors contacts as applicable, including CROs and study site staff as needed.
Assist in study specific document management, including finalization, distribution, and document revision management and archiving.
？ Assist in ancillary supply management, including ordering, distribution, and tracking.
？ Ensure the current study status and tracking of trial related information is available at all times in the appropriate clinical trial management system(s) (CTMS). Work with CRO, Local Trial Managers and Site Managers to ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial.
？ Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to agreed upon timelines/milestones.
？ Responsible for review/management of Trial Master File (TMF) for completeness and timely provision of TMF content across all GCDO functions.
Support running GCDO dashboards & metrics reports with option to provide status analysis.
？ Coordinate and participate in internal and external study specific meetings, as necessary, and document outcomes, actions, and decisions. Follow-up to resolution when required.
？ Support medication related activities e.g. shipment tracking for non IWRS trials, coordination of relabeling, recall, product quality compliant, TMEQ, and TOR management and follow-up.
？ Maintain key trial specific information including contact lists and set-up of study specific training curriculum, and follow up on training completion.
？ Support quality oversight and inspection readiness activities.
？ Work with internal partners to assist in management of activities such as country and site feasibility, and obtaining country-specific clinical trial insurance.
？ Work with internal partners, and external vendors including Contract Research Organization/Academic Research Organization for outsourced trials/activities.
？ Assist GTL and CTM with applicable system support, (i.e., ARIBA, Totality), tracking of vendor work orders and change orders, tracking and analyzing the trial budget, including actual vs. plan trial budget spend, follow-up on variances as needed.
？ Provide overview of data management metrics as needed, including status of data entry/missing pages, source data verification progress, and query resolution.
？ Other activities as delegated by the CTM, GTL, and/or GPL 举报 分享

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.