Senior Clinical Study Start-Up Lead

Lead clinical study start-up and site activation activities at ICON Strategic Solutions, managing regulatory submissions and essential documents globally. Work in a sponsor-dedicated model supported by ICON expertise.

As a Senior Start-Up Manager, you will manage country-level activities across the clinical research environment. Your work includes regulatory documentation, submission processes, CTMS updates, and eTMF document collection. Collaborate with CRAs and Local Study Teams to achieve milestones efficiently.

Key Responsibilities:

• Manage country-level study start-up and site activation activities
• Prepare, review, track, and manage regulatory documentation
• Submit applications and documents to authorities and ethics committees
• Update CTMS and other systems within required timelines
• Collect essential documents and support eTMF quality checks

Requirements:

• Bachelor’s degree, preferably in life sciences
• Minimum five years’ clinical research experience focusing on start-up
• Strong project management skills and regulatory process understanding
• Excellent written and verbal communication abilities
• Ability to manage deadlines and multiple priorities efficiently

Apply clinical research, regulatory submission, and project management expertise to deliver compliant study start-up milestones at ICON.

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