临床项目管理，上市后 (职位编号：31076924)社

面议

市辖区本科及以上7年及以上

发布时间：2023-09-06

职位描述

YOUR TASKS AND RESPONSIBILITIES

1. Manage company sponsored study
Ensuring assigned post-marketing studies implementation in accordance with protocol, SOPs and timeline, throughout the whole process of trial, for example but not limited; investigator meeting, trial initiation, contract, recruitment, data clean, CSR, payment, close.Conduct study feasibility; input in concept/protocol; propose on study timeline and budget. Involve in study strategy making. Present project in 1st tier assessment/Integrated Study Review.Develop study related necessary documents.Submit study periodic progress report.Conduct quality management and issue handling.Safety report management.Manage study budget and cost that meet company requirements, cooperating with MA.FMV assessment, contract and payment tracking.Cooperate well with other stakeholders, including TA, PV, medical compliance, HEOR, RA, GPM, GPT.Keep close communication with leading PI and site; Keep positive relationship with principle investigators and investigators.Be responsible for study drug provision, study insurance for interventional study.For PAC study, delivery the study with high quality and within the timeline to meet regulatory purpose and good result in inspection.2. Manage investigator/institution initiated study (IIR)
Work with MA for IIR budget and timeline planningFMV assessment, contract and payment trackingTrack study progressBe responsible for study drug provision if appropriateMaintain study related necessary documentsSAE report management3. Window person for assigned Therapeutic area
Communicate study status with TA regularly; facilitate in new proposalParticipate IMT meetingPlay important role in TA PMS rolling forecast4. Manage CRO for outsourced study
Select appropriate CRO according to the company process and project needs, cooperating with the ProcurementWork with CRO or business partner to ensure all studies in China on trackSupervise CRO's performance in the project, responsible to train and communicate Bayer's SOP, requirement and police to CRO5. Take tasks as line manager assigned if applicable

WHO YOU ARE

Bachelor degree or above, major in clinical medicine or pharmacologyMore than 5 year experience in clinical research area is mandatory. Experience of leading post marketing study is preferredEffective communication/negotiation skillGood written and oral English for communication within BayerGood computer skillTeam work spir*******************

其他要求

招聘人数：1人
职能类别：临床研究经理CRM

公司介绍

拜耳是一家全球化创新型企业，在生命科学领域的健康与营养方面具有核心竞争力。拜耳致力于以创新的产品帮助解决当今人类社会所面临的一些重大挑战。随着人类预期寿命不断延长，人口不断增长，拜耳通过专注于预防、缓解和治疗疾病的研发活动来改善人们的生活质量。与此同时，拜耳通过突破性创新引领农业未来，帮助农户、消费者得到健康、安全、可负担的食物，并且生产过程对社区、对环境友好。“拜耳：科技创造美好生活”是我们的使命，我们的目标是改善人们的生活质量。

拜耳于1863年创立，迄今已有150多年的历史，公司总部位于德国勒沃库森，全球拥有超过11万名员工。2018年财富世界500强排行榜中拜耳排名193位。早在1882年拜耳公司首次进入中国市场，至今已经超过130年。随着中国成为世界上增长最快的市场之一，拜耳也逐步加大了在这里的投入。拜耳中国总部位于上海，截至2018年12月底，拥有超过9,000名员工。2018年拜耳中国的销售额达到31.27亿欧元，折合人民币超过235亿元。

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