FSP CTM
Thermo Fisher Scientific
Clinical Trial Manager position at Thermo Fisher Scientific responsible for managing operational and quality aspects of low-to-moderate complexity clinical studies. Ensures timely delivery of clinical data and deliverables while maintaining profitability and compliance with ICH GCP standards.
Responsibilities
- Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP standards
- Develop clinical tools including monitoring plans, guidelines, and contribute to Master Action Plan and Trial Master File preparation
- Lead clinical team coordination and communicate with study sites regarding protocol, patient participation, and case report form issues
- Monitor clinical trial progress using tracking tools, prepare activity timelines and metrics, and implement recovery actions as needed
- Manage clinical resources, conduct accompanied field visits in smaller regions, and oversee regulatory/ethics committee submissions
Requirements
- Bachelor's degree or equivalent formal academic/vocational qualification
- 5+ years relevant experience in clinical operations or trial management
- Strong knowledge of ICH GCP, FDA guidelines, and clinical monitoring practices
- Leadership and team mentoring capabilities with strong organizational skills
- Solid financial acumen and budgeting/forecasting knowledge
- Proficiency in Outlook, Excel, Word, and clinical trial management systems
Vacancy posted 2 days ago
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