Senior Data Manager_Remote @ US/CAN (Contract role)

Overview

The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the studies from design through final analysis and study closeout. The individual is accountable for ensuring study launch, conduct, and closeout are performed according to client quality standards, Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to be compliant with all federal and local regulations.

In Short

• Act as Lead Data Manager across one or more clinical studies.
• Provide expertise and oversight of all clinical database activities.
• Review protocols for appropriate data capture.
• Support CRF design and validation of clinical database.
• Conduct oversight of data management vendors.
• Generate, resolve, and track data queries.
• Facilitate and participate in data cleaning activities.
• Generate and review study documents.
• Maintain internal data management timelines and metrics.
• Participate in process improvement activities.

Requirements

• Minimum BA/BS in scientific or health-related field.
• 5 - 7 years of clinical data management experience.
• Oncology or auto-immune experience required.
• Understanding of regulatory guidelines and industry standards.
• Proficient with Medidata RAVE.
• Experience with Medidata Suite products preferred.
• Familiarity with data visualization and reporting tools.
• Excellent communication skills.
• Ability to multi-task in a fast-paced environment.
• Strong organizational skills.

Benefits

• Work directly for a single sponsor.
• Career opportunities with a global CRO.
• Supportive culture and professional development.
• Opportunity to work independently.
• Engagement in process improvement activities.