临床数据管理经理 Clinical Data Manager招聘_基石药业（苏州）有限公司最新招聘信息-猎才医药网

职位描述

职位描述： About Position – DM Manager/ Sr. ManagerDepartment:Clinical DevelopmentEmployment Status:Full time employeeWorking Location:Shanghai, ChinaOverviewProvides DM Leadership and subject matter expertise in the planning and delivery of Data Management activities to time, cost and quality. Responsible for overseeing and managing the execution and overall quality of DM deliverables via external partners for the assigned projects.Responsibilities?Serves as the expert in Clinical Data Management to provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverablesoProvide DM business expertise and consultancy in the selection and use of software systems and vendorsoManages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organizationoContributes to the overall strategy for Data ManagementoProvides input to the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.oServe as internal expert by ensuring the appropriate SOPs and guidelines are followed. Stay abreast of regulatory updates.?Drive the development and oversight of Data Management Standard & Process in partnership with DM service providersoInputs on develop of DM process/practice, identifies areas of improvement and recommends changes to the operating model in partnership with DM vendoroOversee quality and consistency with Company Strategies and Standards across ProjectsoProvide technical level process expertise and conduct periodic assessments to ensure established processes are being followed in a consistent and timely manner.?Management and Oversight of vendor contracts, resourcing and budgetsoReviews, assesses and manages DM delivery against KPIs and overall DM vendor performanceoProvides input into the contract process for the DM vendoroManages all DM timelines and DM Deliverables for assigned Projects?Operational ResponsibilitiesoAccountable for the execution and overall quality of DM activities and deliverables via DM vendors.oReview the CRF design, DB specifications, DMP and other DM documentations as needed to ensure Quality and consistency with DM strategies and standardsoProvide guidance and supervision to CRO Lead Data Managers working on the studiesoPoint of contact for internal team for DM related issues/escalationEducation/Qualification?Minimum of BS in life sciences or computer science degree with at least 5 years of clinical data management experience.?Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management (Preferred)Qualification/Abilities?Demonstrated knowledge of clinical and pharmaceutical drug development process?Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities?Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)?State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting?Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)?Demonstrated understanding of clinical data system design / development / validation and system interoperability.?Demonstrated leadership (including in an outsourced environment)?Demonstrated project management skills?Strong communication and interpersonal skills?Ability to work independently?Demonstrated ability to work effectively with external partners?Ability to negotiate and influence others across functional areas?Fluent in written and verbal English?Effective problem and conflict solving skills?High attention to detail and accuracy?Willing and able to learn quickly in a fast-paced environment?Excellent team player?Title and compensation commensurate with qualifications and experience 职能类别：临床数据分析员其他

公司信息

CStone Pharmaceuticals is an innovative, research-based, biopharmaceutical company committed to the development of a new generation of therapeutic drugs. Based in both Shanghai and Suzhou, the company's leadership team consists of seasoned executives from top pharmaceutical MNCs. In July 2016, CStone announced the completion of its Series A financing, raising a total of US$150 million (about 975 million RMB). Three prestigious investment companies in the industry, Oriza Seed Venture Capital (Oriza Seed), Boyu Capital, and WuXi Healthcare Ventures (WXHV), jointly invested in the round. With an overarching commitment to meeting the most pressing needs of Chinese patients, the company's pipeline covers five therapeutic areas, including oncology, cardiovascular diseases, rheumatoid arthritis, hematology and autoimmune diseases. With immuno-oncology as CStone's core therapeutic focus, the company strives to lead Chinese research to the global market through its world class R&D team, its innovative portfolio, and an open innovation strategy.基石药业是一家创新的研发驱动型生物制药公司，致力于开发新一代的治疗性药物，创立于中国上海和苏州两地，公司的领导团队由来自国际顶尖药企的管理层成员组成。 2016年7月宣布完成A轮融资，共募集到1.5亿美元（约9.75亿人民币）资金，由三家颇具声望的投资公司参与，分别是元禾原点创业投资管理有限公司、博裕资本及毓承资本。目前，基石药业拥有肿瘤、心血管、风湿性关节炎、血液病及自身免疫病等五个治疗领域的产品线，旨在满足中国病患重大迫切的临床需求。在广受瞩目的肿瘤治疗领域，基石药业以其出色的肿瘤免疫药物为核心，凭借其世界级的研发团队，最前沿的药物研发项目，以及开放式创新的策略有望引领国内新药研发行业走向全球。

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： 2017-11-15

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