Added
15 days ago
Type
Full time
Salary
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Related skills

etmf veeva vault tmf ich-gcp fda regulations
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📋 Description

  • Supports operational execution of clinical trials from start-up to close-out.
  • Partners with Clinical Trial Leaders, study teams, CROs, and vendors for compliant trials.
  • Manages TMF filing, maintenance, reconciliation, and inspection readiness per ICH-GCP.
  • Tracks essential study documentation, CTA and budget status, and enrollment metrics.
  • Coordinates study team, vendor, and site meetings; prepares agenda and minutes.

🎯 Requirements

  • Bachelor’s degree in a scientific field; 1-2 years in clinical research.
  • Knowledge of ICH-GCP and FDA regulations.
  • Experience with TMF/eTMF systems (e.g., Veeva Vault).
  • Strong MS Office skills (Excel, Word, PowerPoint, Outlook) and TEAMS.
  • Ability to travel; English verbal and written skills.
  • Oncology experience and CRO oversight preferred.

🎁 Benefits

  • Career advancement opportunities
  • Competitive compensation package and annual bonus
  • 401K + employer contributions
  • Generous stock options and ESPP
  • Paid time off (PTO) and holidays
  • Commuter stipend (Boston Office)
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