Remote Senior Clinical Data Analyst - Medidata RAVE Expert

Parexel; United States; Remote; USD 13,000 - 22,000; Full time

Job summary

Parexel is seeking a Senior Clinical Data Analyst to join our team in a remote capacity based in India. You will support clinical data management activities that advance new treatments, contribute to study execution, patient safety oversight, and regulatory compliance across the data lifecycle.

Responsibilities include database design/management, data quality oversight, vendor coordination, and ensuring proper eTMF filing.

Qualifications

• 8+ years of end-to-end CDM experience.
• Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems.
• Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes.
• Experience authoring/reviewing DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines.
• Strong communication, organization, and problem-solving skills.

Responsibilities

• Support the Data Management Lead in study planning, execution, and project management activities.
• Draft EDC build timelines and perform database and edit check specification activities.
• Conduct user acceptance testing (UAT) for database, coding, site payment, and safety integrations.
• Create and maintain study documents and filing in the eTMF per study requirements.
• Coordinate data review activities, manage vendor deliverables, and support Data Quality Review meetings.
• Manage post-production activities, data migration, and database lock to ensure regulatory compliance and study timelines.
• Provide training and mentoring to junior CDM staff and support cross-functional study teams.

Skills

End-to-end CDM

Data quality oversight

Vendor coordination

Regulatory compliance

Team collaboration

Tools

Medidata RAVE

Oracle Clinical

Job description

Parexel is seeking a Senior Clinical Data Analyst to join our team in a remote capacity based in India. You will support clinical data management activities that advance new treatments, contribute to study execution, patient safety oversight, and regulatory compliance across the data lifecycle.

Responsibilities include database design/management, data quality oversight, vendor coordination, and ensuring proper eTMF filing.