IQVIA is hiring a Clinical Monitoring Analyst (Cluepoints) for a fully remote role. You will function as a Lead programmer on Cluepoints (Centralized Monitoring Analyst) as part of a sponsor-dedicated project, directly supporting the client. Your work will be pivotal in executing the Centralized Monitoring process by handling setup, programming, and refresh of the platform according to study-specific plans.
What You'll Do
- Support the Centralized Monitoring Lead (CML) in developing a fit-for-purpose CM strategy by contributing to identifying relevant CM elements.
- Setup and program Quality Tolerance Limits (QTL), Key Risk Indicators (KRI), and Data Quality Assessments per the study Centralized Monitoring Plan.
- Refresh the Centralized Monitoring Platform at a predefined frequency to enable signal identification.
- Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF.
- Review and understand the study protocol.
- Understand the data sources, transfer specifications, and data structure for the study.
- Execute and document peer-review of CM platform setup done by other CMA colleagues.
What We're Looking For
- At least 3 years of relevant experience in pharmaceutical research and development or a related field.
- Ability to work autonomously and engage with stakeholders to execute study-level centralized monitoring activities.
- Ability to understand basic statistical analysis concepts and 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 teams locally and globally.
- Advanced knowledge of federal regulations, Good Clinical Practice (GCP), and Good Clinical Data Management Practices.
- Excellent command, both verbal and written, of English.
- This role is not eligible for UK visa sponsorship.
Nice to Have
- Experience preferably in Centralized Monitoring, data management, and/or biostatistics.
- 2-3 years SAS experience preferred, including macro language.
- Knowledge or experience working on Cluepoints.
Technical Stack
- SAS
- Cluepoints
- Relational Databases
- Clinical Data Management Systems
- EDC Systems
Team & Environment
You will be part of a sponsor-dedicated project, working directly with the client, and will support the Centralized Monitoring Lead (CML).
Work Mode
This is a fully remote position.
