Sr. Clinical Trial Manager Consultant

Added
15 days ago
Type
Contract
Salary
Salary not provided

Related skills

clinical trials oncology fda ich-gcp regulatory compliance

📋 Description

  • Provide daily oversight for international trials; ensure on-time, on-budget data.
  • Develop and execute operational plans for oncology trials in-house.
  • Collaborate with cross-functional teams to ensure data quality and regulatory compliance.
  • Manage trial start-up: site selection, feasibility, and start-up docs.
  • Monitor progress; identify risks and implement corrective actions.
  • Ensure regulatory compliance (ICH-GCP, FDA) throughout trial lifecycle.

🎯 Requirements

  • Bachelor's or advanced degree in a relevant scientific discipline.
  • Minimum 5 years in Clinical Operations; oncology trial mgmt preferred.
  • Knowledge of ICH-GCP and FDA guidelines for oncology trials.
  • Experience managing trials from start-up to closeout.
  • Strong project management, prioritization, budgeting, and resourcing.
  • Proficiency with Veeva CTMS.
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