FSP Bench Clinical Trial Manager
Thermo Fisher Scientific · Remote
Clinical OperationsRemoteFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Clinical Trial Manager to oversee operational and quality aspects of clinical studies of low to moderate complexity. The role involves managing deliverables within contract specifications, ensuring compliance with ICH GCP standards, and collaborating across teams to meet timelines and quality expectations.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 5+ years of experience in clinical operations or directly related field
- Solid understanding of ICH/GCP, FDA guidelines, and regulatory requirements
- Strong leadership, mentoring, and team integration capabilities
- Proficiency with clinical monitoring practices, processes, and requirements
- Excellent organizational, planning, and financial acumen skills
- Fluent English with strong written and oral communication abilities
What you'll be doing
- Manage clinical operational and quality aspects of assigned studies in compliance with ICH GCP standards
- Develop clinical tools including monitoring plans, data quality plans, and trial master files
- Prepare and monitor clinical activity timelines, metrics, and deliverables to meet contractual obligations
- Lead and coordinate clinical teams, conduct monitoring activities, and resolve case report form queries
- Coordinate study start-up activities and ensure regulatory submissions and ethics committee requirements are addressed
Privacy & handoff
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