Clinical Data Manager Job at Katalyst HealthCares and Life Sciences, South Plainfield, NJ

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  • Katalyst HealthCares and Life Sciences
  • South Plainfield, NJ

Job Description

Responsibilities:
  • Provide comprehensive data management support to the Center 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 in a related field and 6 years of clinical data management related experience.
  • Demonstrated proficiency with data abstraction, query resolution, data reporting and analysis.
  • 6 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.
  • MD, RN, MBA or BS with ongoing accreditation and certifications (CCRP) is a plus.
Katalyst HealthCares and Life Sciences

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