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