Senior Clinical Data Manager – Trial Data & Compliance

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 60,000 - 75,000; Full time

Job summary

Biological Sciences Division at the University of Chicago is seeking a Senior Clinical Research Data Manager to support data management for complex clinical studies under PI oversight. You will ensure data accuracy, integrity, and timely submission across multiple trials, coordinating with sponsors, CROs, and regulators.

The role requires 2–5 years in clinical research data management, a bachelor’s degree, and strong proficiency with standard software.

Qualifications

• Minimum requirements include a college or university degree in related field.
• Bachelor's degree is preferred.

Responsibilities

• 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.
• 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.
• Provides data management expertise to the team in identifying opportunities for improvement.
• Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
• May delegate tasks to team members within the study program.
• Demonstrates proficiency in the use of clinical and research-related computer programs.
• 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.
• Utilizes analytical thinking, attention to detail, and problem-solving skills.
• 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.
• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
• 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. Primary study assignments are considered a higher risk in terms of impact on the reputation and integrity of cancer centers and are generally provided less oversight from external clinical trial monitoring.
• Coordinates document collection and review in collaboration with the principal investigator (PI).
• Performs other related work as needed.

Skills

Data management

Clinical research

Communication

Training others

Detail oriented

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

Biological Sciences Division at the University of Chicago is seeking a Senior Clinical Research Data Manager to support data management for complex clinical studies under PI oversight. You will ensure data accuracy, integrity, and timely submission across multiple trials, coordinating with sponsors, CROs, and regulators.

The role requires 2–5 years in clinical research data management, a bachelor’s degree, and strong proficiency with standard software.