岗位职责:
This position is a member of the Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Data Visualizations, and supporting programming tools. Specifically,
?Manage the quality and delivery of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports as part of standard data validation and reporting package for clinical studies.
?Provide oversight on the programming specifications for the data validation and reporting deliverables; code, test, and document deliverables conforming to programming standards, data quality and governance, and validation policies.
?Partner with the study data managers to develop and confirm programming specifications, support adhoc external data reporting and listings needs, and manage quality expectations in collaboration with internal and external stakeholders.
?Proactively identify and resolve issues that may influence and/or impact study quality and other deliverables.
?Manage and mitigate quality and delivery risks to ensure adherence to timelines, and quality thresholds.
资历要求:
Experiences:
- Two or more years of Clinical Trial Experience in the device/pharmaceutical/CRO industry;
- expertise in Clinical Programming, methods, and techniques;
- expertise in the use of standard reporting and data visualization tools including Spotfire, tableau, JReview and SAS tools;
- knowledge of CDISC and CDASH standards;
- knowledge and understanding of industry standard clinical technologies including EDC, CTMS, and IRT.
Competencies:
- Programming methods and techniques
- Work collaboratively with people at different levels of experience, different disciplines, and cultures
- Self-directed; able to work independently
- Critical thinking and complex problem-solving skills
- Ability to manage multiple priorities
- Background in programming development, project management, validation, execution, maintenance, documentation, and archival of clinical data
- Expertise in supporting and handling external data; viewing and integrating data in multiple formats including SAS
- Knowledge of industry standards, medical terminology, and clinical trial methodologies
上班地址:-上海-南京西路1717号