The Section of Hematology/Oncology at The University of Chicago needs a Senior Clinical Research Data Manager to perform complex and technical data management duties to support clinical research studies, ensuring adherence to protocols and the quality of received information.
Requirements
- Proven excellence in data management.
- Perform data monitoring, query generation and query resolution.
- Perform research data management with minimal supervision.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat.
- Knowledge of medical and/or clinical trial terminology.
- Experience troubleshooting clinical trials; uncovering issues and identifying the most appropriate intervention.
- Knowledge in relevant scientific field.
Responsibilities
- Oversees the data management activities of a specific work unit as the data management expert.
- Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within an assigned study or studies.
- Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
- Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
- Accountable for all data management tasks in support of moderate to high-complexity clinical research studies, which may include a mix of industry, investigator-initiated trials (IITs), and National Cancer Trial Network (NCTN) trials, under limited supervision and while maintaining a high degree of confidentiality.
- Perform data monitoring, query generation and query resolution.
- Perform research data management with minimal supervision.
Other
- Maintains a close, collaborative working relationship with the PIs in your department to effectively manage research studies, with the department, administrative team, and department staff.
- Builds and maintains effective relationships with key study personnel, clinical resources and colleagues.
- May delegate tasks to team members within the study program.
- Facilitates communication between the site and study sponsor, CRO, and/or regulators, and exhibits teamwork skills necessary for managing the data collection and reporting process.
- Will train other data managers within the unit.
