Project Manager, Overseas Clinical Trials 上海

月薪： 1.5-2.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 通讯补贴
  • 年终奖金
  • 定期体检

职位描述

职位描述： POSITION DETAILSPosition name:Project Manager, Overseas Clinical TrialsReports to:VP, Head of Clinical OperationsDepartment:Clinical MedicineLocation:ShanghaiKEY RESPONSIBILITIES?Serves as an operational leader for clinical study teams?Ensures that clinical trials are carried out in accordance with ICG-GCP, local regulations, and Sponsor or delegated agent SOPsJOB REQUIREMENTS1.Responsible for driving cross-functional alignment to strategic plans and goals;2.Ensures that cost, time, and quality parameters are clearly outlined in the plans;3.Communicates and collaborates with study team members, including but not limited to: Statisticians, Medical Managers, Data Managers, Safety Associates, Medical Writers;4.Manages key documents and ensure they are kept current and accessible: ICFs, clinical trial implementation plan, monitoring plan, risk management plan, and various types of committee work plans;5.Ensures and facilitates the completion of relevant documents, including but not limited to: Statistical Analysis Plan (SAP), Data Management Plan (DMP), Safety Management Plan (SMP), etc.;6.Conducts relevant training to members of the study team;7.Responsible for the management of CROs and vendors;8.Coordinates site selection and maintains a good relationship with the selection of clinical trial research sites;9.Responsible for coordinating the application of clinical trial sample collection to ensure that it is in accordance with the requirements of the regulations and research centers;10.Responsible for coordinating study team meetings and/ or supporting CRA site start-up, as well as maintaining good communication with research sites;11.Responsible for tracking the overall progress of the trial, the progress and quality of data collection, reviewing the CRA monitoring report, and working with the research team to conduct regular monitoring;12.Assesses the risks and follows-up with the monitoring of study sites;13.At the end of the clinical trial, coordinates the closure of site(s), including but not limited to drug recovery, final quality verification, archiving of all documents, and supporting the write-up of the study;14.Establishes and manages clinical trial documentation based on ICH-GCP and Sponsor SOP requirements, if applicable.COMPETENCY REQUIREMENTS?Ability to quality-manage clinical trials?Has good leadership and execution skills?Good English communication skills (written and verbal); at least English level CET6?Ability to work independently, but at the same time has a good sense of teamwork?Ability to problem-solve and risk-manage?Ability to adapt under pressureSKILL REQUIREMENTS?Solid knowledge of the overall drug development process and local regulatory requirements?Familiar with ICH-GCP guidance?Ability to present and provide study updates to external and internal stakeholders?Can independently access relevant literature?Basic knowledge of computer skills and Office software applicationsDESIRABLE BACKGROUND?Education requirement: Bachelor’s degree or above?Professional requirements: Medicine, health, pharmaceutical or CRO experience?Work experience: At least 5 years of work experience with at least 2 years in clinical trial management 职能类别： 临床研究员 医药技术研发管理人员 关键字： Project Manager 项目经理 Clinical Trial 临床试验管理

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公司信息

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内最大的抗肿瘤药和手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。 公司先后被评为“全国医药系统先进集体”、“国家重点高新技术企业”，国家火炬计划新医药研究开发及产业化基地的骨干企业之一，“国家863计划成果产业化基地”，连续多年被国家统计局列为全国化学制药行业十佳效益企业；公司是国家“重大新药创制”专项创新药孵化器基地，是“中国抗肿瘤药物技术创新产学研联盟”的牵头单位；2011年，公司组建的国家靶向药物工程技术研究中心成为江苏省医药企业建立的第一家***工程技术中心；公司位列医药上市企业最具竞争力前三。2013年，公司实现营业收入62.03亿元。 恒瑞医药本着“诚实守信 质量第一”的经营原则，致力于抗肿瘤药、手术用药、造影剂、心血管药及抗感染药等领域的创新发展并逐步形成品牌优势。公司是国内首次通过国家新版GMP认证的制药企业之一，同时也是国内第一家注射剂获准在欧美上市销售的制药企业，在中国制药发展史上具有里程碑的意义。目前公司已有3个注射剂、2个固体制剂、5个原料药通过美国FDA和欧盟认证。 在市场竞争的实践中，恒瑞医药坚持以科技创新为动力，致力于打造企业的核心竞争力。为此，公司在美国、上海、成都和连云港建有四大研究中心和一个临床医学部，拥有各类高层次专业技术人员1200余名，其中有500多名博士、硕士及海归人士，有4人被列入国家“千人计划”，7人被列入“江苏省高层次创新创业人才引进计划”。公司建立了***企业技术中心和博士后科研工作站。2011年9月，公司糖尿病科研团队在江苏省科技创新团队评选中名列第一。 近年来，公司先后承担了4项国家863计划重大科技专项项目、23个项目列入国家“重大新药创制”专项，12项国家火炬计划项目，7项国家星火计划项目，23项***重点新产品项目及数十项省级科技攻关项目。公司共申请了近200项发明专利，其中97项PCT专利，有1个创新药艾瑞昔布已获批上市，2个创新药已申报生产，另有9个创新药处于不同的临床阶段。 恒心致远，瑞颐人生。恒瑞医药一直秉承“科研为本，创造健康生活”的理念，以建设中国人的跨国制药集团为总体目标，拼搏进取、勇于创新，不断实现企业发展的新跨越和新突破。 上海盛迪医药有限公司是江苏恒瑞医药有限公司的全资子公司。公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积41000平方米，设有恒瑞新药研发、临床研究、专利注册、医学事务及产品市场管理等核心部门。公司将坚持创新与国际化发展战略，全力打造成为恒瑞医药的创新研发中心。

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