Remote Clinical Study Manager - Lead High-Impact Trials

Canaan Partners

United States

Remote

USD 120,000 - 180,000

Full time

4 days ago
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Job summary

Liquidia is seeking a Clinical Study Manager to lead clinical operations initiatives, supporting studies from startup through reporting in a highly collaborative, virtual environment. The role may be based at our Research Triangle Park HQ or remote.

The ideal candidate has 5+ years in clinical research, strong vendor management experience, and solid knowledge of GCP and FDA regulations, with proven ability to manage budgets and cross-functional teams across internal and external partners.

Qualifications

  • Bachelor’s degree and 5+ years in clinical research.
  • 2+ years in clinical project/study management.
  • Experience qualifying and managing external vendors (CROs, call centers, central labs).
  • Experience leading program teams through start-up, conduct, data management and reporting.
  • Knowledge of GCP and US FDA regulations.

Responsibilities

  • Lead start-up, study conduct, data management and reporting activities.
  • Coordinate with Medical, CMC, PRINT Teams, and QA management.
  • Manage CROs and vendors and oversee budgets and payments.
  • Maintain TMF and ensure regulatory and quality compliance.
  • Train sites on protocol and ensure proper site adherence.
  • Draft/ vet trial materials and vendor proposals as required.

Skills

Leadership
Cross-functional teamwork
Communication
Organization
Problem solving
Travel readiness

Education

Bachelor’s degree in science/related field
5+ years in clinical research
2+ years clinical project/study management
Vendor management experience
GxP and FDA regulatory knowledge

Tools

MS Office
MS Project

Job description

Liquidia is seeking a Clinical Study Manager to lead clinical operations initiatives, supporting studies from startup through reporting in a highly collaborative, virtual environment. The role may be based at our Research Triangle Park HQ or remote.

The ideal candidate has 5+ years in clinical research, strong vendor management experience, and solid knowledge of GCP and FDA regulations, with proven ability to manage budgets and cross-functional teams across internal and external partners.

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