Job Description

Responsibilities:

Provide comprehensive data management support to the Centre for Cancer Research/CCR intramural clinical trials program.

Manage the delivery of high-quality data from project start-up and planning to project execution and closeout.

Independently perform project specific quality control and quality assurance tasks.

Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practices, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.

Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously.

Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.

Test new processes and systems for the management of data in clinical trials.

Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.

Process, track and validate data accurately and on time.

Perform data abstraction and data entry on several different protocols into multiple clinical research databases.

Develop and extract patient clinical data reports for publications and presentations.

Identify project specific reports and assist in the development of these reports.

Prepare, review, and submit clinical data to monitoring agencies.

Maintain client communication regarding data management project status and review key project questions with clients.

Requirements:

BS/BA in a health related field and 5 years of clinical data management related experience.

Demonstrated proficiency with data abstraction, query resolution, data reporting and analysis.

5 years in a medical, clinical or research related study.

Proficiency with clinical databases and report tools.

MS in a health-related field is a plus.

Experience or knowledge of clinical or medical oncology research is a plus.

Certifications (CCRP) is a plus.

Job Tags

Permanent employment,

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