Clinical Study Manager - Remote

Overview

A Clinical Study Manager (CSM) is responsible for overseeing the planning, execution, and close of clinical trials to ensure they are successful and conducted in compliance with regulatory requirements, study protocols, and company standards.

In Short

• Oversee planning and execution of clinical trials
• Conduct feasibility assessments and site selection
• Collaborate with cross-functional teams for protocol development
• Lead daily operations ensuring adherence to protocols
• Identify risks and implement corrective actions
• Coordinate regulatory documentation submissions
• Ensure trial readiness for audits and inspections
• Support preparation of clinical study reports
• Manage study budgets and timelines
• Oversee close-out visits and site document archiving

Requirements

• Bachelor’s degree in life sciences or related field
• 3-5 years of research experience, 2 years in study management
• Knowledge of ICH-GCP, FDA, EMA regulations
• Strong organizational and communication skills
• Project management and leadership abilities
• Attention to detail and multitasking skills
• Conflict resolution and problem-solving skills
• Familiarity with clinical trial management systems

Benefits

• Opportunity to lead impactful clinical studies
• Work in a collaborative environment
• Engage with cross-functional teams
• Professional development opportunities
• Competitive salary and benefits package