数据管理Data Specialist

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 2年工作经验 | 硕士

2023-12-22发布

招聘人数:1人

20-25K/月

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职位信息

Position Summary Responsible for ensuring the completeness, timeliness, quality and integrity of the Clinical Trial data. Ensure data quality and consistency per applicable regulatory requirements, SOP(s), Processes and data standards. Works with the project team to meet the study objectives. May lead data management projects and act as the go-to-person or point of contact. Location: Shanghai; Wuhan; or homebased in other cities Key Responsibilities - General 1. Ensure that all data management activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements. 2. Ensures Conformance to CDISC standard. 3. Continuous learn clinical development knowledge and data management related skills and knowledge. - Hands-on data management responsibilities 1. Ensure timely set-up of data collection mechanisms per CDISC or applicable data standards. 2. Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy. 3. Perform and ensure quality and timeliness of data management activities as specified in DMP. Perform data cleaning activities including discrepancy management and review of data listings to verify quality and completeness of data. 4. Ensure integrity of clinical data and update database by issuing and resolving queries as necessary. 5. Reconcile the patient database with the Serious Adverse Event database. 6. Document all efforts of data management and file all responsible documents. Education and Key Competency Requirements 1. Degrees in life science, such as medical, pharmacology, biological, etc. 2. At least 2+ years experience in clinical data management, clinical trial operation or related functions. Key Competency Requirement 1. Knowledge of GCP and regulatory requirements of clinical trials. 2. Knowledge of data management activities and processes. 3. Work independently, receives instruction primarily on unusual situations. 4. Strong customer service orientation. 5. Effective plan and organize work for delivery within timeline, and able to prioritize to manage of multi-tasks. 6. Attention to details with high quality standards. 7. Communicate effectively and appropriately with internal & external team including vendors and clients. 8. Work with project teams to identify and articulate complex problems. 9. Effective interpersonal skills and collaborative team player. 10. Effective project management skills. 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。
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