Clinical Monitoring Analyst
New
United StatesFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 3 years relevant experience in the area of pharmaceutical research and development or related field
- Required Skills
- Data visualization
Requirements
- At least 3 years relevant experience in the area of pharmaceutical research and development or related field.
- 2-3 years SAS experience including macro language.
- Knowledge or experience working on Cluepoints.
- Prior experience in a Data Management related field.
- Experience with relational databases, preferably Clinical Data Management and EDC Systems.
- Advanced knowledge of federal regulations, Good Clinical Practice (GCP), and Good Clinical Data Management Practices.
- Excellent command, both verbal and written, of English.
- Ability to interpret statistical analysis outcomes.
- Ability to work in an autonomous way and engage with relevant stakeholders.
Responsibilities
- Support the Centralized Monitoring Lead in the development of the fit-for purpose CM strategy.
- Contribute to the identification of the relevant CM elements to be implemented for the study (QTL, KRI, data visualizations and Data Quality Assessments).
- Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP.
- Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification.
- Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF.
- Review and interpret protocol.
- Understand the data sources for the study, the data transfer specifications and the data structure.
- Execute and document peer-review of CM platform setup done by other CMA colleagues.
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