Clinical Trial Manager: Lead Global Studies & Data Quality

Regulatory Jobs

North Carolina

On-site

USD 90,000 - 130,000

Full time

2 days ago
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Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Manager to drive operational excellence on low-to-moderate complexity studies. You will manage data quality, timelines, and cross-functional collaboration to meet contract deliverables.

Responsibilities include developing monitoring plans, overseeing the Trial Master File, and coordinating with sites and internal teams to ensure compliant, on-time study execution. Strong knowledge of ICH-GCP and FDA guidelines is required.

Qualifications

  • Bachelor's degree or equivalent in a relevant field.
  • 5+ years of clinical trial management experience.
  • Experience with ICH-GCP and FDA guidelines.

Responsibilities

  • Manage clinical operations and quality for low-to-moderate complexity studies.
  • Develop monitoring plans and Master Action Plan for trials.
  • Coordinate Trial Master File setup and document quality.
  • Lead team meetings; track timelines, resources and budgets.
  • Ensure regulatory submissions and ethics approvals are addressed.
  • Support forecast estimates and resource allocation.

Skills

Leadership
Planning
Cross-functional collaboration
English communication
Budgeting & forecasting
Outlook
Excel
Word

Education

Bachelor's degree or equivalent
5+ years clinical trial management experience

Tools

Outlook
Excel
Word

Job description

Thermo Fisher Scientific is seeking a Clinical Trial Manager to drive operational excellence on low-to-moderate complexity studies. You will manage data quality, timelines, and cross-functional collaboration to meet contract deliverables.

Responsibilities include developing monitoring plans, overseeing the Trial Master File, and coordinating with sites and internal teams to ensure compliant, on-time study execution. Strong knowledge of ICH-GCP and FDA guidelines is required.

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