- Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, 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 understanding of protocol is key
- 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
Experience:
- At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring, data management, and/or biostatistics
- 2-3 years SAS experience including macro language
- Knowledge/ experience working on Cluepoints
- Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process.
- Ability to understand basic statistical analysis concepts and to interpret their outcome.
- Ability to maintain confidentiality of data and information during interactions with staff at all levels
- Ability to work with limited close supervision.
- Demonstrated communication, interpersonal, organizational and problem-solving skills
- High levels of initiative, drive and commitment.
- Prior experience in a Data Management related field is required
- Experience with relational databases, preferably Clinical Data Management and EDC Systems
- Experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
- Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
- Excellent command, both verbal and written, of English