Clinical Trial Manager, FSP

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 study timelines, ensuring regulatory compliance, coordinating with clinical teams, and delivering final clinical deliverables within contractual specifications.

Responsibilities

• Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP
• Develop clinical tools including monitoring plans and contribute to Trial Master File organization
• Lead clinical team meetings and coordinate across departments to meet project deliverables
• Monitor study timelines, metrics, and CRF collection; implement recovery actions as needed
• Conduct site communications regarding protocol, patient participation, and case report forms

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 5+ years of experience in clinical operations or related field
• Solid understanding of ICH/GCP and FDA guidelines
• Strong leadership, planning, and organizational skills
• Financial acumen and budgeting knowledge
• Proficiency with standard office software and clinical systems