Study Start-up Lead

Lead clinical study start-up activities at country level for a global contract research organization. Manage regulatory documentation, site activation, and compliance with ICH-GCP guidelines while collaborating with clinical teams to meet study milestones efficiently.

Responsibilities

• Prepare, review, and track site regulatory documentation and essential trial documents
• Manage regulatory submissions to authorities and institutional review boards during start-up
• Maintain and report on site performance metrics and study milestone achievement
• Update clinical trial management systems with site data according to required timelines
• Coordinate with clinical research associates and local study teams to resolve outstanding actions

Requirements

• Bachelor's degree, preferably in life sciences
• Minimum 5 years clinical research experience focused on study start-up
• Strong project management and regulatory submission process knowledge
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and meet tight deadlines
• Legal right to work in the country where role is based