FSP CTM
Thermo Fisher Scientific
Clinical Trial Manager position at Thermo Fisher Scientific responsible for managing clinical operations and delivering study outcomes on time and within budget. Oversee low-to-moderate complexity trials, ensure regulatory compliance, and lead cross-functional teams in a remote capacity.
Responsibilities
- Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP standards
- Develop clinical tools including monitoring plans, data quality plans, and trial master file documentation
- Lead team meetings and coordinate clinical activities to meet project timelines and deliverables
- Monitor study progress, track metrics, resolve CRF queries, and implement corrective actions
- Communicate with study sites on protocol compliance, patient participation, and case report forms
Requirements
- Bachelor's degree or equivalent formal qualification
- 5+ years of experience in clinical trial management or related field
- Proficiency in ICH GCP, FDA guidelines, and regulatory requirements
- Strong leadership and team mentoring capabilities
- Fluent English written and oral communication skills
- Financial acumen with budgeting and resource management experience
- Proficiency with clinical monitoring tools and standard office software
Vaga publicada há 4 horas atrás
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