Clinical Data Manager III
Clinical Data Manager III
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This position is primarily a study / team lead Clinical Data Manager. It supports multiple clinical study teams by ensuring all study related clinical data management deliverables are completed with a high degree of quality and within timelines. Participates in and/or leads the crossfunctional study team as the clinical data management knowledge expert. This position is contingent based upon continued funding and may be temporary.
Responsibilities
Participate or lead the crossfunctional project team as the clinical data management knowledge expert. Contribute to the design of protocols forms and data collection processes. Troubleshoot and implement solutions to issues that arise during the development management and close out of clinical studies. Develop timeline for clinical data management deliverables and ensure they are completed. Manage and/or complete all study level data management activities with a high degree of quality. Work with the Manager of CDM to create modify and implement data management processes. Provide inhouse expertise on data management related technical subject matter. (i.e. CDISC 21 CFR Part 11 Systems validation etc. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead.
Minimum Qualifications
Bachelors degree in the life sciences pharmacy nursing a related subject or equivalency (one year of education can be substituted for two years of related work experience). Requires five or more years of relevant clinical data management experience. Possess indepth understanding of the conduct and regulations involving clinical trials clinical data management and clinical data systems such as Federal FDA regulations and requirements governing the conduct of clinical trials including but not limited to GCP and ICH requirements. Possess indepth knowledge and understanding of all data management systems and data handling procedures. Demonstrated ability to independently perform all data management activities associated with a clinical trial with minimal oversight and a high degree of quality. Possess all skills knowledge and competencies required of the CDM I and CDM II positions.
Required Experience:
Manager
Employment Type
Full Time
