Data Manager

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 3-4年工作经验 | 本科

2020-05-20发布

招聘人数:若干

100000-250000元/年

申请职位

职位信息

职位概述Position Summary * 确保临床试验数据的真实性,完整性和准确性。Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data. * 依据相应法规,标准操作规程,流程和数据标准,确保数据质量和数据一致性。Ensure data quality and consistency according to applicable regulatory requirements, SOP(s), Processes and data standards. * 与项目团队合作完成工作。Works with the project team to meet the study objectives. 主要职能Key Responsibilities * 确保数据管理工作符合GCP,相应法规及标准操作规程的要求。Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI(work instructions) of dMed and/or Sponor * 确保执行CDISC或相适用的数据标准。Ensure following and applying CDISC or applicable standard through Clinical Trail. * 确保遵守并符合缔脉和/或相关客户SOP流程,主要职能包括但不限于Follow and keep compliance with dMed and/or Sponsor SOPs, work instructions to be knowledgeable in applicable sections as bellows, but limited to: * 数据录入、清理/Data Entry, clean * 病历报告表(CRF)的收集、整理及追踪/CRF collections, maintenance and tracking. * 按工作分配进行文档文件撰写/create the relevant documentations/files as assigned. * 辅助准备及完成数据质控检验/Assist on prepare and complete the data quality control assessment. * 辅助进行最终数据交付并确保最终符合合理预期/Assist on the final data delivery and ensure to be consistent with Client reasonable expectations and contractual needs. * 参与内外部稽查和行政监查。Ready to participate in internal/external audits and regulatory inspections * 确保了解、遵守并符合缔脉政策制度(Policy)和流程。Ensure acknowledge, follow and to be consistent with dMed Policies and procedures 学历与工作经验Education & Experience Requirement - 自然科学,医学,数据管理相关学位或学历。Degrees in a natural/medical science, data management or related discipline. - 临床试验相关工作经验,了解CFDA的法规要求。Working experience of clinical development process, understanding CFDA requirements of clinical trials - 已有的数据管理工作经验,包括但不限于病例报告表设计,数据库设计,逻辑检查,数据管理计划和数据清理。Previous experience within a data management role, understanding of process including CRF design, database set-up, edit check specification, DMPs and data cleaning activities - 临床试验数据及其附属程序的经验。Knowledge of clinical trial database and its applications - 熟悉多种数据收集方式及数据管理平台。Familiar with mutiple ways of data collection and data managment systmem; 主要能力要求Key Competency Requirement - GCP和临床试验法规相关知识和经验。Knowledge of GCP and regulatory requirements of clinical trials - 数据管理相关工作经验。Knowledge of data management activities and processes - 善于并主动积极寻求解决问题的方法。Be good at soloving problem towards new business needs and alwasy be proactive. - 特定情况时,能在有限的指导下独立工作。Work independently, receives instruction primarily on unusual situations - 完成项目进度,且能在多任务下区分优先级。Work under timeline and priorities of multi-tasks - 有效且妥善的与内部和外部团队成员合作和沟通,包括供应商和客户。Communicate effectively and appropriately with internal & external team including vendors and clients - 与项目团队成员共同识别,并解决复杂问题。Work with project teams to identify and articulate complex problems 备注: ‘职位月薪’ 仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
查看该公司所有职位