The Section of Hematology/Oncology at The University of Chicago needs to ensure adherence to protocols and quality of information received for clinical research studies conducted by principal investigators, requiring a Senior Clinical Research Data Manager to perform complex and technical data management duties.
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.
- Train junior data managers.
- Experience troubleshooting clinical trials; uncovering issues and identifying the most appropriate intervention.
Responsibilities
- 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.
- Performs data monitoring, query generation and query resolution.
- Perform research data management with minimal supervision.
- Experience troubleshooting clinical trials; uncovering issues and identifying the most appropriate intervention.
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.
- Maintains a high degree of confidentiality with clinical data and client's proprietary data.
