Clinical Data Manager 2 - Katalyst Healthcares & Life Sciences
Jacksonville, NC 28540
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
