Sr Study Operations Specialist

We are hiring a Senior Study Specialist (SS) to join a Global Study Operations team.

In this role, you will support and/or lead key clinical study activities including site oversight, vendor management, TMF maintenance, and cross-functional study execution. You will work with increasing independence to ensure study quality, timelines, compliance, and budget adherence.

Key Responsibilities

• Support study setup, documentation, and feasibility/site selection activities
• Oversee CRO deliverables including IRB/EC submissions and approvals
• Manage essential study documents and TMF compliance
• Support investigator training, meetings, and ClinicalTrials.gov updates
• Coordinate vendor oversight, budgets, and clinical trial insurance
• Contribute to risk identification and cross-functional study meetings

Requirements

• BA/BS (life sciences, nursing, health-related field preferred) or equivalent experience
• Clinical research/pharma/biotech experience required
• Experience with CRO/vendor oversight and budget/SOW management
• Strong understanding of clinical trial operations and compliance

If this sounds like a fit, apply now.

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