Clinical Trial Manager / Sr. (CTM) - NIS (Non-Interventional Studies)
Thermo Fisher Scientific · Austin, TX
Clinical OperationsFull timeCompany career page
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Role summary
Senior Clinical Trial Manager position managing non-interventional studies of moderate to high complexity. Responsible for delivering clinical data and study outcomes within contractual timelines while maintaining quality and profitability through efficient team and resource management.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 8+ years relevant clinical operations or trial management experience
- Comprehensive understanding of ICH GCP, clinical monitoring practices, and FDA regulations
- Strong leadership, mentoring, and team management capabilities
- Financial acumen with budgeting, forecasting, and fiscal management skills
- Excellent written and oral communication skills with English proficiency
What you'll be doing
- Manage clinical operations and quality aspects of moderate to high complexity studies in compliance with ICH GCP standards
- Develop clinical tools including monitoring plans, data quality plans, and trial master file documentation
- Lead clinical team, conduct accompanied field visits, and ensure timeline and deliverable achievement
- Communicate with study sites on protocol, patient participation, and case report form issues
- Monitor project financials and clinical resource allocation to maintain profitability within contract scope
Privacy & handoff
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