Lead Clinical Research Data Manager

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 Lead Clinical Research Data Manager leads and provides expertise to the development of programs for the collection, documentation, analysis of clinical trial data for high complexity clinical research studies, and reporting of clinical research data. Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University

Responsibilities

• Accountable for all data management tasks in support of high complexity clinical research studies independently.

• Oversees document collection and review in collaboration with the Principal Investigator (PI), ensuring a high degree of confidentiality, while also providing expertise on the fundamentals of clinical research and related aspects of clinical studies to colleagues with less experience.

• Solves complex problems relating to data management and the analysis of large administrative datasets.

• Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Uses expertise by leading quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups and conducts root cause analysis, assists in development of preventative action plan.

• Accountable for all tasks in complex clinical studies.

• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

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

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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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 and attention to detail.

• Handle competing demands with diplomacy and enthusiasm.

• Strong data management skills and attention to detail.

• 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.

• Analytical skills.

• 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.

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