Senior Clinical Trial Manager - Remote

Overview

This position manages overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management.

In Short

• Manages clinical study operations
• Oversees CRO and vendor management
• Develops project plans and budgets
• Ensures compliance with GCP and regulatory guidelines
• Collaborates with cross-functional teams
• Tracks submissions and approvals to regulatory bodies
• Responsible for study activities from start to closeout
• Provides direction to junior team members
• Contributes to process improvements
• May have line management responsibilities

Requirements

• Bachelor’s degree in Life Sciences or equivalent
• 5+ years of experience in clinical operations
• Experience managing a CRO and complex studies
• Global Clinical Trial experience in Phase 2 and/or Phase 3
• Exceptional attention to detail and organizational skills
• Excellent communication and project management skills
• Knowledge of ICH/GCP and regulatory guidelines
• Ability to travel if required
• Experience in Rare Disease or Neuromuscular drug development is a plus
• Inspection readiness experience is a plus

Benefits

• Base salary range of $171,000 to $189,000
• Annual and spot bonuses, stock options, and RSUs
• 401(k) with employer match
• Comprehensive wellness program
• Four weeks of time off
• Commitment to learning and development