上海招聘

临床项目助理，open北京上海, 经验1-5年

Responsibilities:
TIME: Work with project team to set up and maintain project schedule. Update timelines within MS Project, CTMS, project governance tool, and other trackers. Escalate when timelines are at risk
COST: Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews; vendor financial tracking & reconciliation; sponsor contract financial tracking & reconciliation; and final project financial reconciliation
SCOPE: Work with Project Lead to conduct Contract vs Study Plan Review. Maintain tracker of out of scope (OOS) work performed. Assist the Project Lead to create Change Order Forms. Provide vendor management, escalating OOS activities to Project Lead.
RISK: Update Xcellerate Risk Identification & Issue Resolution (RIIM) tool; and follow outstanding action items to resolution. Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library. Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM
QUALITY: Update Project Governance Tool on a monthly basis. Support the study team to identify, prevent and close quality compliance gaps. Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to documenting issues that may occur during the study. Support study team to ensure timely closure of audit/inspection CAPAs
TEAM COMMUNICATION: Facilitate study team communication & collaboration by attending & setting up team meetings; updating the ADI log; updating the Task Order Matrix; maintaining the Project Directory; setting up distribution lists, SP sites, mailboxes, and other collaboration tools; and set up / maintain project-specific trackers
TEAM COLLABORATION: Collaborate with other support functions to facilitate timely TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curriculum, and other delegated tasks. Monitor for, escalate, and help to enforce redaction of subject sensitive information and identifiers in any study documentation
LESSONS LEARNED: Work with Study Team to maintain Lessons Learned tracker
OTHER: Performs other duties as requested by Line Manager, Project Lead, or other business leaders.


Requirements:
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
1-5 years of relevant industry experience
Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point)
Ability to develop accurate study related documents with minimal supervision
Ability to communicate verbally and in writing
Ability to mentor junior staf

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。

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