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.