Clinical Trial Manager/Senior Clinical Trial Manager

Added
1 hour ago
Type
Full time
Salary
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Related skills

gcp clinical monitoring regulatory ctms ip

📋 Description

  • Lead planning, conduct and oversight of operational portions of clinical studies per scope.
  • Ensure studies conform to protocol, SOPs, ICH-GCP and regulatory requirements.
  • Coordinate with PM on monthly invoicing and budget variance management.
  • Develop study documents and training materials (clinical plans, ICF templates, CRF guidelines
  • Drive site feasibility and recruitment/retention planning with stakeholders.
  • Oversee site start-up, enrollment, maintenance and close-out procedures.

🎯 Requirements

  • Bachelor’s degree in science/health; advanced degree preferred.
  • 7+ years clinical research experience with significant monitoring.
  • Strong knowledge of ICH-GCP, regulatory guidance, and SOPs.
  • Excellent communication, organizational, and negotiation skills.
  • Ability to travel domestically and internationally (incl. overnight).

🎁 Benefits

  • Competitive compensation and bonus eligibility.
  • Health, retirement, life and disability benefits; parental leave; PTO.
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