Description
We are seeking a Centralized Monitoring Analyst (CMA) to join our team as a Lead programmer on Cluepoints. As a CMA, you will contribute to the execution of the Centralized Monitoring process by performing the setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study-specific Centralized Monitoring Plan (CMP).
Main responsibilities include:
- Supporting the Centralized Monitoring Lead (CML) in the development of the fit-for-purpose CM strategy
- Setting up and programming QTL, KRI and Data Quality Assessments according to the study CMP
- Refreshing the Centralized Monitoring Platform at predefined frequency to enable signal identification
- Generating and maintaining the Centralized Monitoring Platform specifications document and filing it in eTMF
- Reviewing and understanding the protocol
- Understanding the data sources for the study, the data transfer specifications and the data structure
- Executing and documenting peer-review of CM platform setup done by other CMA colleagues
Requirements:
- At least 3 years of relevant experience in pharmaceutical research and development or a related field
- 2-3 years of SAS experience, including macro language
- Knowledge and experience working on Cluepoints
- Ability to work autonomously and engage with relevant stakeholders
- Strong communication, interpersonal, organisational 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
- Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
- Excellent command of English