Senior Clinical Research Data Manager

Department
 

BSD MED - Hematology and Oncology - Clinical Research Data Managers - Cluster 5

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, with the administrative team, and the department staff.

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

• 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.

• Trains 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.

• Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.

• Accountable for all tasks in moderately complex clinical studies.

• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.

• 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 2-5 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.<