Senior Clinical Research Data Manager

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

Department

BSD MED - Hematology and Oncology - Clinical Research Data Managers

About The Department

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Summary

The Senior Clinical Research Data Manager will perform a variety of data management duties of a complex and technical nature in support of clinical research studies conducted by principal investigators (PIs) for the clinical research program to ensure adherence to protocols and quality of information received.

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.

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• Progressively responsible relevant clinical research experience.

Technical Skills Or Knowledge:

• 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.


• Knowledge in relevant scientific field.

Preferred Competencies:

• Strong analytical skills.


• Handle competing demands with diplomacy and enthusiasm.


• Strong data management skills.


• Work collaboratively and with divisional research offices.


• Maintain a high degree of confidentiality with clinical data and client's proprietary data.


• Adaptability to changing working situations and work assignments.


• Work independently and as part of a team.


• Strong attention to detail.


• Excellent multi-tasking skills.

Application Documents

• Resume/CV (required)


• Cover Letter (required)

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

FLSA Status

Exempt

Pay Range

$60,000.00 - $75,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case based and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

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