Clinical Trial Manager / Sr. (CTM) - NIS (Non-Interventional Studies)
Thermo Fisher Scientific Inc
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 5 days ago
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