南京招聘

职位描述：
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以下基础工作：Follow and keep compliance with dMed and/or Sponsor SOPs, work instructions to be knowledgeable in applicable sections as bellows, but limited to the peer Hands-on tasks:

* 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

- 担当一个或多个临床试验数据管理的项目负责人。Act as project leader on data management for one or more clinical trials:

* 按需参与内部职能会议Participate internal functional meetings as required.

* 总体监察并报告所有职责范围内临床试验及工作状况。Oversee review and report all responding trial and task status as required.

* 项目监控，确保所有试验可交付成果按时按质完成。Project monitor and ensure trail deliverables to be in terms of timelines and quality.

* 对可辨识的流程和技术问题敏感，对数据可交付成果进行风险管理。To be Sensitive on all identifiable solutions for process and technical issues, Risk management on any data quality deliverables.

- 日常工作以提供相应技术支持Manage routine works to provide technical support:

* 临床数据核查，辅助相应数据一致性核查、检讨方案违背及资质评估以确保临床试验数据质量。Review on the clinical data and ensure clinical data quality by assisting with all relevant data reconciliations, protocol deviation review and eligibility assessment as appropriate.

* 开发试验数据库/EDC系统，创建相应文件，保持合理数据库权责以遵守数据库实施操作/终止规程，满足相应数据库释放、冻结、锁定和解锁需求。Develop trial database/EDC, create relevant documentations and files as required, follow database conduct/closure procedures for keeping appropriate ownership of Clinical database on releasing, freezing, locking and unlocking requirements.

- 指导培训其他团队成员，包括但不仅限于初级数据管理员Mentor and train other team members, including but not limited to junior data manager:

* 以已确定的SOP，工作指南，缔脉和/或客户培训为基础进行工作任务级别流程与培训的交付。Deliver task level process and training from established SOP, work instructions, dMed and/or Sponsor trainings.

* 在试验特定培训上指导初级数据管理员。Mentor Junior Data manager on trial specific level trainings.

* 通过对规程、问题点和绩效提供可辨识化的、经考量过的、明确的客观反馈以促进团体建设。Contribute on team development by providing identified, balanced, clear objective feedback on procedures, issues and performances.

- 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

- 项目管理和供应商管理经验。Project Management and vendor management experience

  

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

- 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。 举报 分享

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我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。