Global study Manager -PM招聘_科文斯医药研发（上海）有限公司最新招聘信息-猎才医药网

职位描述

Responsibilities / Duties In his Global Study Manager role, the Study Manager II is accountable to ensure global consistency of the Diaganostic programs across the different laboratory principal investigator testing sites where the diagnostic trial is conducted. He is in charge to coordinate the regulatory aspects with the appropriate operational groups including Medical Affair and Quality Assurance departments General duties: Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager and the DDS Global Study ManagerAct as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.Participate in Covance CLS development through continuous process improvement, quality and productivityDemonstrate through appropriate self-organization the ability to manage high administrative loadAble to act efficiently in an environment with dynamic timelines and prioritiesDemonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budgetUpon management assignment, the Study Manager I may be assigned with Global Study Management duties.In his Global Study Manager role, the Study Manager I is accountable to:Ensure global consistency of the Dx program across the different testing sites location, including lab operation processes harmonization, Implement, monitor, set up local performance metrics and take corrective actions when needed, Pre win consultation support with the Dx client and the commercial development department.Manage and monitor the Diagnostic Sponsor budget in collaboration with PM Global study Manager Act as ambassador on behalf of the Diagnostic client across Covance departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills Act as regional internal liaison to ensure proper and smooth communication between the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design planPrincipal Day-to-Day duties study related activities- including but not limited to:(80% of time in a single work week)Prepare, organize and host CRA visits as needed.Participate into and prepare Client Audit related to Diagnostic studiesPrepare, coordinate set up and monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved Submit regulatory authority applicationsManage and lead external and internal meetings Track monthly Diagnostic services billable activitiesReport Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/ScientistReport protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/ScientistEnsures that all customer expectations are documented and acted upon in compliance with regulatory requirementsServe as back up to Regional Study Coordinators and Study ManagersGlobal Study Management responsibilities:Ensure laboratory processes harmonization across CLS sites location.Ensure Diagnostic protocols and program consistency across CLS sites location Ensure proper escalation of internal misalignment and inconsistencies and propose corrective and preventive actionsManage, monitor Diagnostic Client Budgets in coordination with the PM global study manager Regulatory/ Study Documentation duties-(20% of time in a single work week)Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.Maintain all necessary study documentation,: study binders, material receipt forms, and material balance formsParticipate in team meetings and take minutesOrganize and Archiving study documentation and correspondence as requested by the clientFiling and collating trial documentation and reportsPerform physical inventory of study materials as neededTrack monthly Diagnostic services billable activitiesReport Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/ScientistReport protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist Education / QualificationsMinimum Required: · BS degree in Biology, Chemistry or other Life Science; or Medical Technologist degree. Preferred: Computer literateProfessional certification (ASCP,PMP or other) in area(s) expertiseExperience Minimum Required: 3 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus. Location: 浦东新区张江高科技园区李冰路151号3号楼职能类别：生物工程/生物制药关键字： Project Management

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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