Senior Clinical Research Data Manager
Department
BSD MED - Hematology and Oncology - Clinical Research Data Managers - Cluster 1
About the Department
Job Summary
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.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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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)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
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
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 basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
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