Independent Drug Monitoring, Manager

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Base: $93,100.00 - $232,800.00; bonus/equity: not ...
Independent drug monitoring
Study setup and blinding
Ongoing study monitoring
The role will be responsible for independent drug monitoring for assigned studies, including end-to-end ownership from initial set up and drug blinding activities to ongoing monitoring and closure

Job Summary

  • The role will be responsible for independent drug monitoring for assigned studies, including end-to-end ownership from initial set up and drug blinding activities to ongoing monitoring and closure.
  • Responsibilities include leading study teams, providing input for pharmacy materials, system set-up support, ensuring quality and adherence to SOPs, and acting as the main point of contact for drug monitoring issues.
  • The position requires developing trial-specific training materials, mentoring junior colleagues, establishing excellent working relationships, and maintaining unblinded TMF for inspection readiness.

Matching Summary

The role will be responsible for independent drug monitoring for assigned studies, including end-to-end ownership from initial set up and drug blinding activities to ongoing monitoring and closure.

Salary

Base: $93,100.00 - $232,800.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Independent drug monitoring
  • Study setup and blinding
  • Ongoing study monitoring
  • Issue escalation and resolution
  • Stakeholder communication
  • Develop monitoring documents
  • ICH-GCP knowledge

Nice-to-have

  • Project management experience
  • Global trial experience
  • Virtual team coordination
  • Solution-oriented approach
  • Presentation development

Key Requirements

  • Bachelor's or University degree or equivalent experience
  • 6 years clinical trial operations experience
  • Monitoring experience recommended
  • Willingness to travel locally/domestically

Work Rights

Not specified

Tailored Resume

Cover Letter