Senior Clinical Trial Manager

Added
23 days ago
Type
Full time
Salary
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Related skills

gcp sop cro fda ivd

πŸ“‹ Description

  • Execute deliverables for assigned clinical studies (startups, site initiation, docs, closeout).
  • Lead and mentor study staff (CRAs/CTAs).
  • Manage vendor/CRO proposals, budgets, contracting, and management.
  • Collaborate with CTMs to share lessons and implement best practices.
  • Provide regular updates on study progress to stakeholders.
  • Ensure compliance with SOPs, FDA/GCP and international regulations.

🎯 Requirements

  • BA/BS and 6+ years in clinical trial mgmt; advanced degree preferred.
  • Strong knowledge of clinical trial operations, design, enrollment, monitoring.
  • Experience managing CROs and external vendors.
  • Working knowledge of CFR Parts 11, 50, 54, 56, 812 and ICH GCP.
  • Ability to work independently and lead/mentor teams; proven PM skills.
  • Excellent problem-solving, verbal and written communication.

🎁 Benefits

  • Equity, bonuses, and comprehensive medical/financial benefits.
  • Remote work with occasional in-person meetings at the Brisbane, California HQ.
  • Equal opportunity employer; values diversity.
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