Global Clinical Trial Manager — Lead & Deliver

NCBioImpact; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead clinical operations and quality for allocated studies, ensuring compliance with ICH GCP. You may take on CSM duties for smaller projects and develop monitoring tools in collaboration with the Data Quality Plan.

You will coordinate start-up activities, collaborate with various teams, and lead standardized monitoring processes while ensuring timely study deliverables and archiving.

Qualifications

• Bachelor's degree or equivalent and relevant formal qualification.
• 5+ years of experience in clinical operations or equivalent.
• Familiarity with ICH/GCP guidelines and regulatory requirements.

Responsibilities

• Oversee clinical operations and quality for allocated studies, including smaller projects with CSM responsibilities.
• Develop clinical tools (e.g., Monitoring Plan, monitoring guidelines) and support Master Action Plan creation.
• Coordinate start-up activities and ensure timely ethics committee and regulatory submissions.

Skills

Leadership

Project management

Communication

Budgeting

Problem solving

English proficiency

Team coordination

Education

Bachelor's degree or equivalent

Tools

Outlook

Excel

Word

Job description

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead clinical operations and quality for allocated studies, ensuring compliance with ICH GCP. You may take on CSM duties for smaller projects and develop monitoring tools in collaboration with the Data Quality Plan.

You will coordinate start-up activities, collaborate with various teams, and lead standardized monitoring processes while ensuring timely study deliverables and archiving.