Clinical Monitoring Analyst (Cluepoints) - Remote
On-siteBloemfontein, Free State, South Africa
Job Summary
Conduct study-specific Centralized Monitoring by setting up, programming, and refreshing the platform according to the Centralized Monitoring Plan. Develop fit-for-purpose strategies including Quality Tolerance Limits, Key Risk Indicators, and data visualizations while generating and maintaining specifications documents in eTMF. Execute peer reviews of platform setups and interpret statistical outcomes from data sources and transfer specifications. Review protocols thoroughly to ensure data structure alignment and manage deliveries directly with the client. Requires 3+ years in pharmaceutical R&D, SAS programming, and Cluepoints experience. Full-time remote role based in Bloemfontein.
Required Qualifications
- SAS experience including macro language
- Knowledge or experience working on Cluepoints
- 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
- 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, and Good Clinical Data Management Practices
- Excellent command, both verbal and written, of English
- Ability to work with limited close supervision
- Ability to maintain confidentiality of data and information during interactions with staff at all levels
- Demonstrated communication, interpersonal, organizational and problem-solving skills
- High levels of initiative, drive and commitment
- Ability to understand basic statistical analysis concepts and to interpret their outcome
- Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process
- Review and understanding of protocol is key
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.