Lead Clinical Trial Manager, Study Delivery & Compliance

ThermoFisher Scientific; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Thermo Fisher Scientific in the United States is seeking a Clinical Trial Manager (FSP Team) to drive delivery of final clinical data within contract timelines. You will lead the clinical team, ensure quality and regulatory compliance, and manage risks across studies of low to moderate complexity.

This role requires strong leadership, budget oversight, and collaboration with sites and stakeholders. Travel domestically and internationally may be required; standard Mon-Fri schedule.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 5+ years of experience in a similar role or equivalent.
• Equivalency may be considered with education, training, and related experience.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. May assume CSM responsibilities on small projects.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) and contribute to the Master Action Plan for providing clinical documents.
• Collaborate with the clinical team and other departments to meet deliverables, lead team meetings, and ensure timelines and budget adherence.
• Prepare and monitor activity timelines and metrics, provide status updates, and review monitoring visit reports.
• Coordinate start-up activities and ensure timely ethics committee and regulatory submissions where appropriate.
• Provide input into forecast estimates for clinical activities and manage resources.

Skills

Leadership

Project management

Clinical operations

ICH GCP

Regulatory compliance

Budgeting & forecasting

Data analysis

Communication skills

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific in the United States is seeking a Clinical Trial Manager (FSP Team) to drive delivery of final clinical data within contract timelines. You will lead the clinical team, ensure quality and regulatory compliance, and manage risks across studies of low to moderate complexity.

This role requires strong leadership, budget oversight, and collaboration with sites and stakeholders. Travel domestically and internationally may be required; standard Mon-Fri schedule.