Clinical Research Data Manager 2

Department
 

BSD MED - Hematology and Oncology - Clinical Research Data Managers - Cluster 2

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 Clinical Research Data Manager 2 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 to effectively manage research studies, with the department, with the administrative team, and the department staff.

• Builds and maintains effective relationships with key study personnel, clinical resources and colleagues throughout.

• 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.

• 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.

• May assist in training other Data Managers within the unit.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• 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 < 2 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Bachelors degree.

Experience:

• Research or relevant experience.

• Well versed in medical and/or clinical trial terminology.

• Background in relevant scientific field.

Technical Skills or Knowledge:

• Proficient in Microsoft Word, Excel and Adobe Acrobat.

Preferred Competencies

• Demonstrated ability to abstract subject data from medical record/source documentation and enter into care report forms and/or databases.

• Background generating and resolving queries and/or monitoring data.

• Handle competing demands with diplomacy and enthusiasm.

• Perform research data management with minimal supervision.

• 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.

• Excellent multi-tasking skills.

• Train junior data managers.

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
 

Research

Role Impact
 

Individual Contributor

FLSA Status
 

Non-Exempt

Pay Frequency
 

Biweekly

Scheduled Weekly Hour