PM/SPM 全国

该职位来源于猎聘 Position Summary: Responsible for large scale and complex clinical trials independently. Taking in charge with the whole project management from the study setup to the closeout. Making sure all the project activities are following the SOPs, applicable regulatory, work scope and clients’ requirements, meeting the demands of quality, timeline and budget request from contract and study. Establish and complete the project management team training materials, the working procedures and the standard of performance assessment. Project Assessment and Initiation:Review the Project contract exhibit to identify staff necessary for the project team.Request project team resources from the appropriate Line Manager(s) when a contract has been awarded.Call the initial team meeting to review the contract and develop project implementation and communication plans.Ensure the company level management system inputs correct and completed.Provide or arrange for project-related training as needed for team members.Prepare and update the Project Management Plan (PMP).Start the project. Project Tracking:Review meeting minutes, external and internal correspondence, all project-related reports (including the study monitors’ site visit reports and telephone reports), follow-up letters, travel itinerary, trip reports, and project expenses.Assure the project is completed within budget, schedule, and according to contract specifications, managing precisely based on ERP/CTMS/eTMF system .Assure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill local regulations.Determine the cause of project overruns, recommend and institute corrective action.Hold project meetings on a regular basis for delegation of responsibilities and tasks to project team members, monitoring the progress of each individual project task, and assessing the overall status of the project, with particular attention to the following:Regulatory document collection and submission.Site start-up status.Enrollment status.Monitor visit reports.Site drug inventories.Serious Adverse Events (SAEs).Data entry status of CRFs .Study close out.Track resources and actual time spent on each project task for all team members to evaluate project progress and profitability.Perform Co-monitoring visit, if necessary. Communications:Communicate to team members the scope of work, timeline and project goals, technical information, and input from clients throughout the project.Inform team members of any new information or modification of project-related issues which may affect specific responsibilities of team members.Report to Line Managers any anticipated need for addition or re-assignment of resources.Communicate to Line Manager any needs or concerns regarding level of training or performance of team members.Provide Line Manager with input regarding team members’ performance as needed for employees' periodic Performance Review.Provide project status input within the agreed monthly timeline to provide management with the required resource reports, forecasts and revenue recognition information.Prepare Administrative Reports and submit to clients as required by the contract.Communicate project issues to Line manager. Others：Bidding Support: Under support of Line manager, assist in the preparation of new project quotation, proposal and bidding materials, and participate in project bidding meeting when necessary.Provide guidance or help to less experienced employees according to the requirements of line manager, if necessary.As the mentor of specific project according to the requirements of line manager, provide support for project quality management, guide project manage to find quality problems in the project, find solutions to problems, and implement rectification and preventive measures, if necessary.May be assigned as the author or reviewer of standard operating procedures related to project management.Participate in the formulation, regular review and modification of standard operation process of project management department.Finish other work assigned by line manager.