北京招聘

Key accountabilities

All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable regulatory requirements. Maintain effective professional relationships with external customers, investigators and vendors. Maintain effective professional relationships with internal project team including those providing academic input. Provide clear guidance to project team on project specific deliverables.

Project Kick-off

• Attend relevant project specific meetings including formal kick-off meetings
• Develop project plan and other internal project management documents.
• Assist the originator of the project in the development of project specific documents such as protocol and participant information forms as requested.
• Coordinate the feasibility planning and selection process of project sites
• Identify project specific activities that need to be out-sourced and be involved in the selection of suitable vendor/s.

Project Implementation and Closure

Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including: ？

• Contribute to the preparation of project specific budget where applicable
• Track budget for allocated portion of project
• Deliver relevant portion of project specific budget by guiding team and vendors on project scope, and forecasting and invoicing as agreed with customer
• Track project scope and propose scope changes for assessment
• Work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable
• Oversee the set-up of sites within relevant region in accordance with SOPs, protocol and all applicable regulatory guidelines
• Contribute to the calculation of project staffing levels ？ Contribute to the identification of appropriate materials for project ？
• Monitor project progress against timelines
  
• Deliver project specific milestones as agreed with customer ？
• Coordinate project administration e.g. study management committee meetings, project newsletters ？
• Coordinate and drive internal project team to meet project specific deadlines ？
• Liaise with centre staff to ensure effective local management ？
• Drive project team to deliver clean, accurate and verifiable data for interim and final analyses ？
• Assist with the development of project documentation e.g. site manuals, operating procedures ？
• Review and sign-off monitoring visit reports ？
• Ensure patient safety and adverse/serious adverse events are reported according to regulatory requirements ？ Initiate filing conventions for the project and team is trained on requirements ？
• File and archive clinical project data at end of project ？
• Provide or contribute to progress reports for project originator and other stakeholders ？
• Maintain regular contact with project team including academic leads ？
• Maintain contact with National Coordinators working within allocated region ？
• Be available as back-up contact for site staff on all project related matters ？
• Where applicable liaise with staff in Data Management and Statistics ？
• Divisions on project specific deliverables

Skills, Knowledge and Experience

• Tertiary qualifications in a related science or health care discipline
• Previous experience working on clinical projects within an academic, CRO or pharmaceutical company environment
• Previous experience supervising project related tasks of other people
• Excellent interpersonal skills, presentation skills and team leadership ability including leading virtual teams in a cross cultural environment and dealing with conflict
• Excellent working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions
• Technological proficiency including Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project), clinical trials management software, and the Internet
• Ability to travel (up to 25%) ？ Ability to see the big picture, yet still focus on detail and quality of work
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

The George Institute China is a medical research institute, and a wholly-owned foreign enterprise, that was established as an affiliated partner with Peking University Health Science Centre in March 2007, whose registered name is Beijing George Medical Research Co. Ltd. The aim of the Institute is to promote high quality medical research through the conduct of randomised controlled trials and epidemiological studies with various government and non-government partners for the purpose of providing evidence-based approaches to improve the health of Chinese people.
George Clinical is the clinical research delivery arm of the George Institute and manages phase I to phase IV clinical studies for both commercial and medical research organisations. George Clinical is recognized as a leading Clinical Research Organisation (CRO) bringing together medical and scientific expertise in the clinical trials area. George Clinical China is a wholly owned foreign enterprise and trades under the name George (Beijing) Clinical Research Co. Ltd.