上海招聘

Responsibilities / Duties：
The CDx (Compagnion Diagnostic) Regional Study Coordinator II is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world.
The CDx Regional Study Coordinator II coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the Dx study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study.
The CDx Regional Study Coordinator II ensures the three ways communication with the regional Diagnostic Client in their specific area of the word, the PM Global Study Manager appointed to the Pharma Sponsor and the regional laboratory operations testing site.

The CDx Regional Study Coordinator II acts as consultant/Technical Expert in providing recommendations/advice to all parties, a-day-to-day project management oversight by managing, planning and coordinating all projects related as well as maintaining study documentation in accordance with customer expectations and in compliance with regulatory requirements.
General duties:
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 plan
Act as regional external liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) the PM Global Study Manager and the internal clients to ensure an outstanding - timely communication
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 Manager
Act 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 productivity
Demonstrate through appropriate self-organization the ability to manage high administrative load
Able to act efficiently in an environment with dynamic timelines and priorities
Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget

Principal Day-to-Day duties

Day-to-day local 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 studies
? Prepare, 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 applications
? Manage and lead external and internal meetings
? Track monthly Diagnostic services billable activities
? Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
? Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
? Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
? Serve as back up to Client Coordinator Specialists and Regional
?
Study CoordinatorsRegulatory/ 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.
? Organize and Archiving study documentation and correspondence as requested by the client
? Filing and collating trial documentation and reports
? Perform physical inventory of study materials as needed
Education / Qualifications：
Minimum Required:
? Medical Technology (MT) degree or Bachelor’s Degree or Equivalent Experience
Preferred:
? Computer literate
? University degree(BS) in a scientific field is a strong plus
? Professional certification (ASCP,PMP or other) in area(s) expertise
Experience：
Minimum Required:
3 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus

LabCorp是全球***的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

欢迎加入科文斯中国团队，我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号，通过移动端迅速查询热招职位并投递申请，与我们并肩实现#CovancePotential。